5 March 2021 - - The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has issued a positive scientific opinion for US-based pharmaceutical company Eli Lilly and Company's (NYSE: LLY) bamlanivimab alone and bamlanivimab administered together with etesevimab, Lilly said.

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.

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%, 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.

Lilly continues to engage with global regulators regarding the potential of both bamlanivimab alone and bamlanivimab and etesevimab together in treating COVID-19, working with regulators to make these therapies available around the world.

The company is focused on areas with the highest disease burden and global allocations are made based on Lilly's guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.

Bamlanivimab alone is authorized under special/emergency pathways, in the context of the pandemic, in numerous countries including Canada, the Czech Republic, Germany, Israel, Italy, Hungary, Sweden, UAE and the US while bamlanivimab and etesevimab together is currently authorized for emergency use in the US and Italy.

In addition, bamlanivimab alone has been authorized for emergency use in Rwanda and Morocco, and through Lilly's work with the Bill and Melinda Gates Foundation, Lilly is providing doses of the medicine free of charge in these countries.