EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients
AbCellera (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.
“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.”
The 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.
Bamlanivimab 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 100,000 doses of bamlanivimab and etesevimab to the U.S. government through to March 31, 2021. The U.S. government will have the option to purchase up to an additional 1,100,000 doses through November 25, 2021. This purchase agreement is in addition to the 1,450,000 doses of bamlanivimab alone that the US government previously committed to purchase: to date, more than 1 million doses have been delivered, and Lilly has agreed to deliver 450,000 additional doses by March 31, 2021. AbCellera is eligible to receive royalties in the low- to mid-teens for aggregate sales below $125.0 million and mid-teens to mid-twenties on aggregate sales above $125.0 million. Sales of bamlanivimab in 2020 were $871 million.