The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Eli Lilly’s COVID-19 antibodies bamlanivimab and etesevimab.
The CHMP opinion recommends using bamlanivimab alone and bamlanivimab administered together with etesevimab for the treatment of confirmed COVID-19 in patients aged 12 years and older, who are at high-risk of progressing to severe COVID-19 and who do not require supplemental oxygen.
According to Lilly, this opinion can be considered by EU member states when making decisions on the use of the antibodies at a national level, before a formal EU marketing authorisation is issued.
The opinion was supported by Phase II and Phase III results from Lilly’s BLAZE-1 trial. In the BLAZE-1 trial, bamlanivimab alone reduced viral load and symptoms and also reduced COVID-19 hospitalisation by approximately 70%.
In addition, bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalisations and death by 70% in non-hospitalised high-risk patients with mild-to-moderated COVID-19.
“[This] 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,” said David Ricks, chairman and chief executive officer of Lilly.
“In addition, other countries look to CHMP advice to support their own reviews. We hope this opinion will accelerate those reviews and authorisations, particularly in low- and middle-income countries, where Lilly is prepared to provide doses at greatly reduced costs or free of charge,” he added.