The Pharma Data

NOVEMBER 9, 2020

We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.” Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). See Limitations of Authorized Use.

Treatment 52

Treatment FDA Hospitals Long-Term Care Facilities 52

The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. ” Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. .

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40

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. ” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. The CHMP scientific opinion under Article 5.3 Lilly Antibody Therapies Around the World.

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Treatment Hospitals Long-Term Care Facilities Therapies 40