CHMP recommends Lilly’s bamlanivimab for COVID-19 patients

pharmafile | March 8, 2021 | News story | Sales and Marketing COVID-19, EMA, Eli Lilly 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for Eli Lilly’s bamlanivimab alone and bamlanivimab administered together with etesevimab in COVID-19 patients.

The committee recommends bamlanivimab alone and bamlanivimab administered together with etesevimab for the treatment of confirmed coronavirus in patients aged 12 years and older that do not require supplemental oxygen, and who are at high risk of progressing to severe COVID-19.

The CHMP’s scientific opinion under Article 5.3 of regulation 726/2004 provides a harmonised, 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 EU marketing authorisation is issued.

To support the recommendation, 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 hospitalisations by approximately 70%. Bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalisations and death by 70% in non-hospitalised, high-risk patients with mild to moderate COVID-19.

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 authorisations, particularly in low- and middle-income countries, where Lilly is prepared to provide doses at greatly reduced costs or free of charge.

“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.”

Darcy Jimenez

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