🇺🇸 Efgartigimod in United States

FDA authorised Efgartigimod on 24 July 2024

Marketing authorisations

FDA — authorised 24 July 2024

Application: BLA761195
Marketing authorisation holder: ARGENX BV
Indication: Labeling
Status: approved

The FDA approved Efgartigimod, developed by ARGENX BV, for the treatment of generalised myasthenia gravis. This approval was granted on 24 July 2024, following a standard expedited pathway. Efgartigimod is a human monoclonal antibody that targets and reduces the levels of autoantibodies responsible for the disease.

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FDA — authorised 17 October 2025

Application: BLA761304
Marketing authorisation holder: ARGENX BV
Indication: Efficacy
Status: approved

The FDA approved Efgartigimod, a monoclonal antibody, for its approved indication. The approval was granted to ARGENX BV following a standard expedited pathway. The application number for this approval is BLA761304.

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Efgartigimod in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Efgartigimod approved in United States?

Yes. FDA authorised it on 24 July 2024; FDA authorised it on 17 October 2025.

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

ARGENX BV holds the US marketing authorisation.