CLINSQUARE: CLINICAL RESEARCH COURSES
Thursday, February 6, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 146

The Drug approval process in EU:

admin
-
0
The Drug approval process in EU:

50 regulatory authorities from the 31 European Economic Area (EEA) countries (28 EU Member States, including Iceland, Liechtenstein and Norway), the European Commission and EMA creates the European medicines regulatory system.

European medicines regulatory system= (European commission + EMA + 50 Regulatory authorities)

This network makes EU regulatory system unique and quite complex. Although this is not its official name, the EMA is also called the European Medicines Assessment Agency or EMEA. It is currently called The European Agency for Medicines.

Before Proceeding into approval process, let’s learn about two common terminologies.

Clinical Trial Application (CTA). It consists of comprehensive information about the investigational medicinal product and details about the proposed/planned trial. Regulatory authority reviews this application and decides about acceptability of conducting a trial.

It can be considered as equivalent to IND (Investigational new drug application) which needs to be submitted to FDA to get permission to initial a trial.

Marketing Authorization Application (MAA): It is an application submitted by a drug manufacturer/sponsor seeking permission to bring a drug product to the market. It can be consider as Equivalent to NDA of US regulatory

The below information covers only drug for human use.

There are four approval paths:

  • Centralised procedure
  • Decentralised procedure
  • Mutual-recognition procedure
  • Nationalized Procedure

Centralized procedure:

  • It allows the marketing of a drug candidate on the basis of a single EU-wide assessment and marketing authorisation which is valid throughout the EU (European Union).
  • Pharmaceutical companies or Sponsor has to submit single application to EMA and The Agency’s Committee for Medicinal Products for Human Use (CHMP) carries out a scientific assessment of the application and gives a recommendation to the European Commission. Based on the recommendation, marketing authorisation can be granted or rejected.
  • Once it is approved, it is valid for all EU member state. The whole process may take around 210 days

Important Note:

The centralized procedure is compulsory in below scenario:
If Human Medicine contains new active substance to treat

  • Cancer, Diabetes, Auto-immune disease, Orphan medicines, products manufactured by mean of biotechnology processes, neurodegenerative disorder, other immune dysfunctions, HIV and viral diseases.
  • Gene-therapy, somatic cell-therapy or tissue-engineered medicines;

It is optional for other medicines:

  • New active substances for  indication other than listed above
  • Significant therapeutic, scientific or technical innovation;
  • Whose authorisation would be in the interest of public health at EU-Level.

Decentralised procedure: 

  • In this procedure the applicants/sponsor can apply for marketing authorization in more than one European Union Member States for those products which have not been yet authorized in any European Union country and also do not come under the list of drugs under compulsory Centralized Procedure category (List mentioned above under “important note”)
  • The whole process may take around 210 days

Mutual Recognition Procedure:
Where applicant/Sponsor that have a drug authorized in one EU member states, can apply for this authorization to be recognized in other EU countries. Member States has to rely on each other’s scientific assessments

  • The member state, where drug is already approved, is called reference member state and concerned member states are the one where applicant is seeking the approval through this process.
  • This whole process can take up to a time period of 390 days.

Nationalized Procedure: In this procedure the applicant is allowed to obtain a marketing authorization in any of the one member states. To get the National Marketing authorization, the applicant needs to submit the application to the competent authority of the member state. It may take up to 210 days.

Generic and Hybrid Medicine approval process:

Generic Medicine:  As per EMA:

“A generic medicine contains the same active substance(s) as the reference medicine, and is used for treating the same disease(s) at the same dose(s). Nevertheless, the inactive ingredients of a generic drug can be specific in name, appearance and packaging.”

Since the safety and efficacy data of the active substance is already available from the reference drug, sponsor/applicant only need to product below information:

  • information on the quality of the medicine;
  • bioequivalence study

Conceptually It is like FDA’ 505 (j) pathway for Generic Drug approval with no Changes or few allowed changes.

Hybrid medicines: As per EMA:

  • Authorization  of Hybrid medicines  depends partly on the results of tests on the reference medicine and partly on new data from clinical trials (New + Old Data)

Hybrid Medicines carries the same active ingredient (as Reference Medicine) but it but has a different strength/route of administration or a slightly different indication from the reference medicine.

  • Additional Clinical trial may be required to test efficacy and/or safety.
  • Conceptually It is like FDA’ 505 b(2) pathway for generic drug with Some changes.

List of Scientific Committees which do the scientific assessment.

Source: https://www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-medicines-european-medicines-agency-consistent-approach-medicines_en.pdf
  • The member state, where the clinical trial is taken place, will be responsible for authorisation and oversight of a clinical trial.
  • The European Clinical Trials Database (EudraCT) tracks all the authorized clinical trial in EU.

Ref: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/generic-hybrid-medicines
https://www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-medicines-european-medicines-agency-consistent-approach-medicines_en.pdf

Big Change in FDA process for Biologics:

admin
-
0
Big Change in FDA process for Biologics:

 “The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).”

This requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020.” as per FDA
It means, after 23-Mar-2020, we will have only BLA pathway for biological product. This 10 year period (2009 to 2020) is given to sponsor so that they can be prepared for this transition.

Background of this change:

As we know that some protein (Not chemically synthesized) products; for example  insulin and insulin analogs, human growth hormone (HGH), reproductive hormones, pancreatic enzymes, used to be  approved by new drug applications (NDAs) pathway under the FD&C Act. As per new changes, these products will be shifted to BLA pathway.

Proteins (NDA pathway) before 23-Mar-2020 
Proteins (BLA pathway) After 23-Mar-2020
You can read about biological product approval pathways in below article https://lifepronow.com/blog/2019/12/27/biologics-approval-pathways-in-usa/

Lets Learn about the details of this new process:

For Proposed Product:
After 23-Mar-2020, Biological products which could have been approved by NDA pathway, will be approved by BLA applications. Sponsor needs to submit an application under section 351 of the PHS Act. Based on the nature of product, application can be either:

  1. 351(a) BLA ( “stand-alone” BLA) for new product
  2. 351(k) BLA for a proposed biosimilar product or a proposed interchangeable product.

For approved products:,
“The BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act on March 23, 2020, and regulated under the PHS Act.”  as per FDA.

  • It means already approved biologics under NDA pathway will be considered as approved (deemed to be a license)  under BLA pathway after 23-Mar-2020.
  • After the transition, sponsor can seek approval of bio-similar or interchangeable biologics of  these transitioned products.

More guidance about interpretation of this act can be found in below link under resource section: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act


U.S. Food and Drug Administration (FDA) approved sNDA to Revise Flexion Therapeutic’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain

admin
-
0
U.S. Food and Drug Administration (FDA) approved sNDA to Revise Flexion Therapeutic’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain

Dec. 26, 2019: Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to revise the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain.

Some important elements of the label update include Removal of language which stated that ZILRETTA was “not intended for the repeat administration.” The restructured label states that the “efficacy and the safety of repeat administration of ZILRETTA have not been demonstrated.”

Removal of the misleading statement describing a single secondary tentative endpoint in the original Phase 3 pivotal trial which compared ZILRETTA to immediate release triamcinolone acetonide crystalline suspension. 

ZILRETTA is indicated as an intra-articular injection and is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

ZILRETTA has not be evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. It should not be considered safe for epidural or intrathecal administration. https://fda.einnews.com/pr_news/505807715/flexion-therapeutics-announces-fda-approval-of-snda-to-revise-zilretta-triamcinolone-acetonide-extended-release-injectable-suspension-product-label

Biologics Approval Pathways in the USA:

admin
-
0
Biologics Approval Pathways in the USA:

Existing Regulatory framework for biologics approval in the US:

Two laws were enacted to regulate drugs in the USA: The Federal Food, Drug, and Cosmetic Act (21 USC § 301, FD&C), and the Public Health Services (PHS) Act (42 USC § 262; PHS).
FDA was empowered by the US government to enforce the Federal Food, Drug, and Cosmetic Act and other laws including a few section of the Public Health Service Act.

There are two divisions in the FDA: Center for Drug Evaluation and Research (CDER) and The Center for Drug Evaluation and Research (CBER).

CBER deals with biological products exclusively  and CDER mainly regulates Chemical drugs but in 2003 FDA has transferred few biological to CDER. Information about biological which was transferred to CDER is mentioned in the second section of this article.

In 2010, the PHS Act was amended to create an abbreviated approval pathway for biosimilars, or biologics which can be considered “highly similar” or interchangeable with FDA authorized drug (reference drug).

This pathway is also known as the Biologics Price Competition and Innovation Act (BPCIA) of 2010 and it is quite similar in concept with the Hatch-Waxman Act of 1984 for generic drugs.

On June 30, 2003, FDA transferred some of the therapeutic biological products that used to be evaluated and regulated by CBER (Center for Biologics Evaluation and Research) to CDER  (Center for Drug Evaluation and Research).

CDER will take care of regulatory aspects including premarket review and persevering with oversight, over the transferred product. In regulating the products assigned to them, CBER and CDER will seek advice from each other often and on every occasion necessary.

Categories of Therapeutic Biological Products Transferred to CDER

  • Monoclonal antibody (invivo use only)
  • Therapeutic protein (obtained from  plants, animals, or microorganisms, and recombinant protein)
  • Immunomodulators (Except vaccine and allergenic product)
  • Growth factors, cytokines and monoclonal antibodies which are meant to modify the production of hematopoietic cells in in vivo.

    Drug approval Process by CDER

Categories of Therapeutic Biological Products Remaining in CBER

  • Cellular products: Human cells, bacterial or animal cells and components of these cells.
  • Gene therapy products.
  • Vaccines 
  • Allergenic extracts
  • Antitoxins, antivenins, and venoms
  • Blood and Blood components
  • Plasma and Plasma Derived products

For combination products, “Intended mode of action by which part” is checked. If a product is a combination of Drug A and Biological B but Mode of action is due to Biological B then as per the assigned category (see above categories), the application will be transferred to either CDER or CBER.

Present Regulatory Pathway for Biologics in US:
1. 351 (a)
2. 351 (k)
3. 505 b(2)

351(a) or Stand Alone Pathway or BLA (Biological License pathway):
It comes under PHC act and it is a traditional pathway used for approval of innovator biologics. Safety and Effectiveness data need to be submitted along with application. 

It is like New drug application (505 b(1)) pathway for drugs which are reviewed by CDER. Robust information about manufacturing facility is also required in BLA application.

351(k) Pathway: It also comes under PHC act. The application is submitted by the manufacturers in order to get a product reviewed as a biosimilar or interchangeable which is considered to be “highly similar” to an FDA licensed reference product.

Let’s know about FDA given definitions:

Biosimilar or Biosimilarity definition  :

“that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and 

there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product.” As per FDA

Interchangeable or Interchangeability Definition: 

“the biological product is bio-similar to the reference product; 

it can be expected to produce the same clinical result . as the reference product in any given patient.

for a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and its reference product is not greater than the risk of using the reference product without such alternation or switch.” as per FDA

Please note that Interchangeable product may be substituted with Ref product without the consent of a Doctor.

Reference Product Definition:

“ the single biological product, licensed under section 351(a) of the PHS Act, against which a biological product is evaluated in an application submitted under section 351(k) of the PHS Act” As per FDA.

 FDA decides which of the following studies are necessary to be included in the application:  
Analytical Studies – Check of comparability between the biological and reference product. It is also done to know any minor difference in clinical inactive ingredients.

Animal Studies – It is done for evaluation of toxicity.

Clinical Studies – Assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD) to establish the safety of the product in the condition of use.

It is important to note that biological product may not be evaluated against more than one Reference product.

General Requirements of 351(k) pathway

  • Intended product Is biosimilar to a reference product;
  • Mechanism of action should be same as reference product
  • Intended Indication for approval should be same to that of Reference product
  • Same Route of administration
  • Same dosage form, strength as per the reference product
  • Detailed information about facility, where Intended product  is manufactured, processed, packed, or held to ensure its safety, purity and potency.
505(b)(2) Pathway:

Prior to the enforcement of  BPCIA to till today 505(b)(2) pathway could be used for certain biologicals. Similar to 351(k) pathway, this pathway allows the applicant to rely on the safety and effectiveness data of a previously-approved product.

The 505(b)(2) pathway is available for a relatively narrow category of biologics specifically, those that had been approved under an New drug application (NDA) before the BPCIA was signed into law in 2010. Examples can be found at below source. https://www.biologicsblog.com/biosimilars-under-505-b-2-pathway-2

Must Read: Big Change in FDA process for Biologics:

Ref:
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/transfer-therapeutic-products-center-drug-evaluation-and-research-cder https://www.freyrsolutions.com/what-is-351a-351k



Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:

admin
-
0
Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:

Few facts before discussing about generic products approval in US:

  • Hatch-Waxman Act: The Drug Price Competition and Patent Term Restoration Act is commonly known as “Hatch-Waxman Act” which was enacted in 1984 as an amendment to Federal Food, Drug, and Cosmetic Act (the “FFDCA”) and the Patent Act.
  • The main goal of this act to expedite the Generic drug approval process and reach the market quickly.  505 (b)2 and 505(b) (j) regulatory pathways were introduced  by this act.
  • Patent information of all the approved product is maintained in orange book.
  • Abbreviated New Drug application (ANDA) is used for generic products approval in US. It comes under 505 (b)(j) section. It is commonly called as 505 (b)(j) pathway of generic drug approval.
    Learn about other of drug approval in USA
    Drug Approval Process in India
    The Drug approval process in EU
    Drug Approval Process in China

Para I, II, III and IV certifications:

ANDA has four type of submission (Section 505(j)(2)(A)(vii); 21 CFR 314.95). They are listed as :

  • Paragraph I certification: when patent is not submitted for drug candidate (No Patent in Orange book). FDA can approve ANDA without delay.
  • Paragraph II certification: when the  Patent gets expired, FDA can approve ANDA without delay.
  • Paragraph III certification: After the particulate date when drug patent is going to be expired, FDA can approve ANDA.
  • Paragraph IV certification:  It is somewhat complicated. applicant files the application to FDA for ANDA paragraph- IV certification. Applicant has to notify the patent holder about this application within 20 days.

Patent holder can files infringement suit against ANDA applicant within 45 days (from receiving of notification by ANDA applicant). In this case, ANDA approval is stayed for 30 months.

source FDA: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM445610.pdf)

It is important to note that 180-day exclusivity is only available to “First to File” (FTF) ANDAs which comes successfully through Paragraph IV certification.

Shared Exclusivity:  Many times there are more than one applicant in “First to file” category. In this case, applicant  share the 180 days exclusivity which can be understood by below graph (source FDA:

source FDA: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM445610.pdf)

Ref: https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/patents-vs-market-exclusivity-why-does-it-take-so-long-to-bring-generics-to-markethttps://www.fda.gov/media/92548/download

fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/paragraph-iv-drug-product-applications-generic-drug-patent-challenge-notifications

for IT certification, follow the path: comptia A+ certification test

U.S. Food and Drug Administration (FDA) approved Allergan’s UBRELVY(ubrogepant) for the acute treatment of migraine with or without aura in adults.

admin
-
0
U.S. Food and Drug Administration (FDA) approved Allergan’s UBRELVY(ubrogepant) for the acute treatment of migraine with or without aura in adults.

Dec. 23, 2019: U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Allergan’s UBRELVY™ (ubrogepant) for the acute treatment of migraine with or without aura in adults.

UBRELVY™ is the first and only orally-administered, highly potent calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start.

Migraine is a neurological disease that is characterized by intermittent migraine attacks with symptoms that are often incapacitating.

Migraine afflicts 31 million Americans and is the thirds general disease and second leading cause of disability worldwide. It provided lasting relief up to 24 hours as well.

UBRELVY™(50 mg,100 mg), block CGRP, a protein that is released during a migraine attack, from binding to its receptors, without constricting blood vessels, which some older treatments are known to do. https://www.allergan.com/News/Details/2019/12/Allergan%20Receives%20US%20FDA%20Approval%20for%20UBRELVY%20for%20the%20Acute%20Treatment%20of%20Migraine%20with%20or%20without%20Au

U.S. FDA approves EISAI’S DAYVIGO™ (LEMBOREXANT) for treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults

admin
-
0
U.S. FDA approves EISAI’S DAYVIGO™ (LEMBOREXANT) for treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults

Dec 23, 2019: Eisai Co. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for its in-house discovered and developed orexin receptor antagonist DAYVIGOTM (lemborexant) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.

It will commercially available in 5 mg and 10 mg tablets following scheduling by the U.S. Drug Enforcement Administration (DEA).

Lemborexant is characterized by difficulties with sleep onset and/or sleep maintenance is supposed to be through antagonism of orexin receptors.

The orexin neuropeptide signaling system plays an important role in wakefulness.Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R is reflection to restrain wake drive.

This approval was based on the results of a clinical development program that incorporated two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated DAYVIGO versus comparators for up to one month and DAYVIGO versus placebo for six-months, respectively, in a totality of about 2,000 adult patients with insomnia. https://www.eisai.com/news/2019/news201993.html

Roche and Sarepta Therapeutics enters licensing agreement in order to improve the lives of patients living with Duchenne muscular dystrophy

admin
-
0
Roche and Sarepta Therapeutics enters licensing agreement in order to improve the lives of patients living with Duchenne muscular dystrophy

Dec 23, 2019: Roche and Sarepta Therapeutics announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin),  Sarepta’s investigational gene therapy for the Duchenne muscular dystrophy (DMD), outside the United States.

Under the conditions of the agreement, Sarepta will receive a direct payment of $750million in cash and $400million in equity. Sarepta is eligible to obtain regulatory and sales milestones and royalties on net sales.

Roche and Sarepta will even contribute to global development expenses. It combines Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for DMD to accelerate access to SRP-9001 for the patients outside the United States.

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death, it affects approximately one in every 3,500 – 5,000 male births worldwide.

SRP-9001, currently in clinical development for the DMD, is designed in order to deliver the microdystrophin-encoding gene directly to the muscle tissue for the targeted production of the microdystrophin protein. https://www.roche.com/media/releases/med-cor-2019-12-23.htm

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)

admin
-
0
FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)

Dec. 23, 2019: FibroGen announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.

Roxadustat (FG-4592) is the first orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that is submitted to FDA regulatory approval for the treatment of anemia of CKD.

Regulatory approval of roxadustat is supported by the positive results from a global Phase 3 program encompassing 15 trials that enrolled above 10,000 patients, worldwide.  https://fda.einnews.com/pr_news/505579171/fibrogen-submits-new-drug-application-to-the-u-s-fda-for-roxadustat-in-patients-with-anemia-of-chronic-kidney-disease

U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s Novel Antipsychotic CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults

admin
-
0
U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s Novel Antipsychotic CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults

Dec. 23, 2019 : U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults, commercial launch of CAPLYTA in late Q1 2020.

The efficacy of CAPLYTA 42mg was established in two placebo-controlled trials, showing a statistically noteworthy separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score.

The general adverse reactions (≥5% and twice the rate of placebo) for the suggested dose of CAPLYTA vs placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%).
https://fda.einnews.com/pr_news/505579239/fda-approves-intra-cellular-therapies-novel-antipsychotic-caplyta-lumateperone-for-the-treatment-of-schizophrenia-in-adults

Zosano Announces FDA Submission of 505(b)(2) New Drug Application for Qtrypta for the acute treatment of migraine

admin
-
0
Zosano Announces FDA Submission of 505(b)(2) New Drug Application for Qtrypta for the acute treatment of migraine

Dec. 23, 2019: Zosano Pharma Corporation announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration (“FDA”) for acute treatment of the migraine.

This NDA submission represents a considerable milestone for Zosano and a culmination of our efforts to make Qtrypta available to patients who suffer from migraine.

After clinical trials, Qtrypta demonstrated robust freedom from pain and most bothersome symptom, rapid and sustained pain relief for the patients suffering from migraine.

This submission is supported by the results of the ZOTRIP pivotal Phase 2/3 clinical study, in which 41.5% of patients treated with the 3.8 mg dose of Qtrypta achieved pain freedom at 2 hours and 68.3% reported freedom from most inconvenient symptom at 2 hours, both of which were co-primary endpoints.

Qtrypta is Zosano’s proprietary formulation of the zolmitriptan delivered utilizing its proprietary Adhesive Dermally-Applied Microarray (ADAM) technology.

Zosano’s ADAM technology consists of titanium microneedles coated with the drug, and in the case of Qtrypta, its formulation of zolmitriptan.  https://fda.einnews.com/pr_news/505583850/zosano-announces-fda-submission-of-new-drug-application-for-qtrypta

U.S FDA issues complete response letter to ViiV Healthcare for the use of investigational cabotegravir and rilpivirine long-acting regimen for the treatment of HIV

admin
-
0
U.S FDA issues complete response letter to ViiV Healthcare for the use of investigational cabotegravir and rilpivirine long-acting regimen for the treatment of HIV

Dec 21, 2019: ViiV Healthcare received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

Cabotegravir is an integrase strand transfer inhibitor that is developed by ViiV Healthcare and rilpivirine – non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. T

he cabotegravir and rilpivirine are long-acting regimen and is an investigational product and not approved anywhere in the world.
https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-receives-complete-response-letter-from-us-fda-for-use-of-investigational-cabotegravir-and-rilpivirine-long-acting-regimen-in-the-treatment-of-hiv/

1...145146147...156Page 146 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved