March 5, 2021: “Eli Lilly and Company announced that the EMA Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.
The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
The CHMP scientific opinion under Article 5.3 of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies.
The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued.
“Today’s CHMP recommendation is another important milestone in our efforts to extend access to antibody therapies for patients with COVID-19 around the world, providing a pathway for more EU countries to enable use of potentially life-saving treatments for COVID-19.
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In addition, other countries look to CHMP advice to support their own reviews. We hope this opinion will accelerate those reviews and authorizations, particularly in low- and middle-income countries, where Lilly is prepared to provide doses at greatly reduced costs or free of charge,” said David A. Ricks, Lilly’s chairman and CEO.
“Lilly is proud that hundreds of thousands of patients globally have already received treatment with our antibody therapy, and we will continue to deliver on our commitment to help high-risk patients who may benefit as the world works to fight this pandemic.”
To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial.
Results from BLAZE-1 demonstrated bamlanivimab alone reduced viral load and symptoms and also reduced COVID-19 hospitalizations by approximately 70 percent, and bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent in non-hospitalized high-risk patients with mild to moderate COVID-19.
Lilly Antibody Therapies Around the World
Lilly continues to engage with global regulators regarding the potential of both bamlanivimab alone and bamlanivimab and etesevimab together in treating COVID-19, working with regulators to make these therapies available around the world.
The company is focused on areas with the highest disease burden and global allocations are made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.
Bamlanivimab alone is authorized under special/emergency pathways, in the context of the pandemic, in numerous countries – including Canada, the Czech Republic, Germany, Israel, Italy, Hungary, Sweden, UAE and the U.S. – while bamlanivimab and etesevimab together is currently authorized for emergency use in the U.S. and Italy.
In addition, bamlanivimab alone has been authorized for emergency use in Rwanda and Morocco, and through Lilly’s work with the Bill & Melinda Gates Foundation, Lilly is providing doses of the medicine free of charge in these countries.
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Important Information about bamlanivimab alone and bamlanivimab and etesevimab together
Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together or bamlanivimab alone are safe and effective for the treatment of COVID-19.
Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and bamlanivimab alone and mandatory requirements of the EUA.
Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab and etesevimab together.
Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab alone.
U.S. Authorized Use and Important Safety Information
Bamlanivimab 700 mg and etesevimab 1400 mg together and bamlanivimab 700 mg alone are authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Limitations of Authorized Use
- Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Benefit of treatment with bamlanivimab alone has not been observed in patients hospitalized due to COVID-19.
- Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Important Safety Information
There are limited clinical data available for bamlanivimab and etesevimab together and bamlanivimab alone.
Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone.
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone.
If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.
Infusion-related reactions have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone.
These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:
- fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.
If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
Clinical Worsening After Bamlanivimab Administration
Clinical worsening of COVID-19 after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status.
Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19.
Limitations of Benefit and Potential Risk in Patients with Severe COVID-19
Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19.
Benefit of treatment with bamlanivimab alone has not been observed in patient hospitalized due to COVID-19.
Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. See Limitations of Authorized Use.
Adverse Events
Bamlanivimab and etesevimab together
Based on Phase 2 data from BLAZE-1, nausea was the most commonly reported adverse event, reported by 4% of subjects in both bamlanivimab and etesevimab together and placebo groups.
Pruritus and pyrexia were more frequently reported from subjects treated with both bamlanivimab and etesevimab (2% and 1%) compared to placebo (1% and 0%, respectively).
Based on Phase 3 data from BLAZE-1, the most common adverse events were nausea, dizziness, and rash.
These events each occurred in 1% of subjects treated with bamlanivimab and etesevimab together and in 1% of placebo subjects.
Bamlanivimab alone
Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%).
Use in Specific Populations
Pregnancy
There are insufficient data on the use of bamlanivimab and etesevimab together and bamlanivimab alone during pregnancy.
Bamlanivimab and etesevimab together and bamlanivimab alone should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
Breastfeeding
There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
Breastfeeding  individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.”
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