Eli Lilly have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for COVID-19 antibodies 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.
To support the opinion, the EMA reviewed Phase II and Phase III 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%, 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.
Although the CHMP opinion applies to EU member states, which does not include England, Scotland or Wales, Lilly believes this is a significant development in the advancement of antibodies and potential COVID therapeutics.
David A. Ricks, Lilly’s chairman and CEO said: “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. 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.”
He continues: “Lilly is proud that hundreds of thousands of patients globally have already received treatment with our2 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.”