🇺🇸 BKEMV in United States

FDA authorised BKEMV on 28 May 2024

Marketing authorisation

FDA — authorised 28 May 2024

Application: BLA761333
Marketing authorisation holder: AMGEN INC
Local brand name: BKEMV
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved BKEMV, a drug developed by AMGEN INC, on 2025-04-18. The approval was granted under the standard expedited pathway and is for a Risk Evaluation and Mitigation Strategy (REMS) indication. The REMS is a requirement for medications with serious safety concerns, and it aims to ensure the safe use of the drug by healthcare providers and patients.

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BKEMV in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is BKEMV approved in United States?

Yes. FDA authorised it on 28 May 2024.

Who is the marketing authorisation holder for BKEMV in United States?

AMGEN INC holds the US marketing authorisation.