February 02, 2023: “AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.
Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.
The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial.
The improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials.
Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said: “Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filledpen as an option that will empower patients and healthcare providers with increased choice.
We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label.
With the approval of the pre-filledpenin the US, we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic.”
Tezspire self-administration and the Tezspire pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries around the world.
Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.
Tezspire will be available as a fixed-dose 210mg subcutaneous injection via a pre-filled, single-use auto-injector (the Tezspire pre-filled pen) or via a pre-filled, single-use syringe (the Tezspire pre-filled syringe). Both are administered every four weeks.
The Tezspire pre-filledpenenables patients and caregivers to self-administer the medicine at home or in clinic via a simple process. The device is fitted with a safety guard and viewing window and has audible clicks at the start and end of the injection to guide patients.
PATH-HOME was a Phase III multi-centre, open-label, parallel-group trial designed to assess patient, caregiver and healthcare provider-reported functionality and performance of a single-use, pre-filled syringe (PFS) or auto-injector (AI) with a fixed 210mg dose of Tezspire administered subcutaneously every four weeksin a clinic and in an at-home setting in 216 patients aged 12 years and older with severe asthma.
The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer the Tezspire pre-filled penboth in the clinic and at home throughout the trial.
At-home administration of the Tezspire pre-filled pen at weeks 12 and 16 was successful in 97% of the patients or caregivers (102/105).
The trial also demonstrated for the first time that adolescents can successfully administer Tezspire using the two devices.
The very low proportion of device malfunctions (0.9% of PFS and 0.8% of AIs) provides support that the instructions for use provided to healthcare providers, patients and caregivers is adequate for successful subcutaneous administration of Tezspire both in the clinic and at home.
PATH-BRIDGE was a single-centre, randomised, open-label, parallel-group Phase I trial in healthy people to compare the pharmacokinetic (PK) exposure following a single 210mg dose of Tezspire by using a vial-and-syringe (V-S), PFS or pre-filled AI device.
Tezspire PK exposure was comparable following subcutaneous administration via V-S, PFS or AI.
In addition, injection site-pain was low in severity and injection-site reactions were uncommon in all device groups.
In addition to PATH-BRIDGE and PATH-HOME, the PATHFINDER clinical trial programme included the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.
NAVIGATOR was the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP).
These results support the FDA Breakthrough Therapy Designation granted to Tezspire in September 2018 for patients with severe asthma, without an eosinophilic phenotype.
In July 2021, Tezspire was the first and only biologic to be granted Priority Review in the US for the treatment of asthma by the FDA.
Tezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.
Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.
Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.
Tezspire acts at the top of the inflammation cascade and has the potential to help address a broad population of severe asthma patients irrespective of biomarker levels.
Tezspire is approved in the US, EU, Japan and other countries for the treatment of severe asthma.
Tezspire is also in development for other potential indications including chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE).
In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.