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EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients
Positive European Union (EU)-level scientific opinion provides a pathway for more EU countries to access the antibodies to treat COVID-19 before formal
About this update from Abcellera Biologics Inc.
[{"type":"text","content":"\nPositive European Union (EU)-level scientific opinion provides a pathway for more EU countries to access the antibodies to treat COVID-19 before formal marketing authorizations are granted\n\n VANCOUVER, British Columbia--(BUSINESS WIRE)--\nAbCellera (Nasdaq: ABCL) today announced that the European Medicines Agency's (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 recommendation provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies, which can be used by EU member states when making decisions on the possible use of the therapies at a national level prior to market authorization.\n\n“Bamlanivimab has been used to treat hundreds of thousands of patients globally, and its impact continues to grow as the use of COVID-19 antibody therapies accelerates,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “Several EU countries have authorized bamlanivimab, and the EMA’s CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need.”\n\nThe EMA reviewed Phase 2 and Phase 3 results from Eli Lilly and Company’s (Lilly) BLAZE-1 trial to support the CHMP opinion. Results from BLAZE-1 demonstrated bamlanivimab alone reduced viral load and rates of symptoms and also reduced hospitalization by approximately 70%, and bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70% in non-hospitalized high-risk patients with mild to moderate COVID-19. Details regarding the CHMP opinion and Lilly’s plans to make COVID-19 therapies broadly available to patients can be found here.\n\nBamlanivimab has been authorized in more than 10 countries, and bamlanivimab together with etesevimab received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on February 9, 2021. The EUA was followed by a $210 million purchase agreement for Lilly to provide 100,00...