Europe Embraces Eli Lilly’s COVID-19 Treatments
Eli Lilly and Company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive scientific opinion for the COVID-19 treatment bamlanivimab alone and bamlanivimab administered with etesevimab.
The new EMA opinion issued on March 5, 2021, can now be considered by the European Union member states when deciding on using the COVID-19 therapies before a formal marketing authorization is issued.
The EMA opinion advises that bamlanivimab alone and bamlanivimab administered together with etesevimab can be used to treat confirmed COVID-19 in patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
To support the opinion, the EMA reviewed Phase 2, and Phase 3 results from Lilly's BLAZE-1 trial that demonstrated bamlanivimab alone reduced viral load and symptoms and also reduced COVID-19 hospitalizations by approximately 70 percent.
Bamlanivimab and etesevimab reduced the risk of COVID-19 hospitalizations and death by 70 percent in non-hospitalized high-risk patients with mild to moderate COVID-19.
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19.
Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor.
"We hope this opinion will accelerate 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," stated David A. Ricks, Lilly's chairman, and CEO, in a press statement.
Bamlanivimab alone is authorized under 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 are currently authorized for emergency use in the U.S. and Italy.
Also, bamlanivimab alone is authorized for emergency use in Rwanda and Morocco. Through Lilly's work with the Bill & Melinda Gates Foundation, Lilly provides doses of the medicine free of charge in these countries.
The FDA has not approved Bamlanivimab and etesevimab together and bamlanivimab alone 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.
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