EMA Issues Advice on bamlanivimab Alone, Administered Together with etesevimab for COVID-19 in EU

Eli Lilly and Company announced 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 scientific opinion under Article 5.3 of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued.

"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," said David A. Ricks, Lilly's chairman and CEO. "Lilly is proud that hundreds of thousands of patients globally have already received treatment with our 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."

To support the opinion, the EMA reviewed Phase 2 and Phase 3 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 percent, and bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent in non-hospitalized high-risk patients with mild to moderate COVID-19.