Policy & Regulation
Bristol Myers Squibb seeks EU approval for subcutaneous nivolumab
21 June 2024 -

Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) said on Friday that it has submitted an extension application to the European Medicines Agency (EMA) for a new subcutaneous formulation of Opdivo (nivolumab).

The application seeks approval across multiple previously approved adult solid tumour indications.

Validation by the EMA initiates the centralised review process.

Subcutaneous Opdivo offers faster administration times compared to the intravenous formulation and could improve the patient experience.

Phase 3 trial data supported the application, demonstrating non-inferiority in efficacy and safety.