The Pharma Data

NOVEMBER 9, 2020

Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). Lilly is in discussions with global regulators to make bamlanivimab available around the world. The authorization is temporary and does not replace the formal review and approval process.

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Treatment FDA Hospitals Long-Term Care Facilities 52

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

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Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

MARCH 11, 2021

” Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing.

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Hospitals Trials Long-Term Care Facilities Treatment 40