🇺🇸 Kygevvi in United States

FDA authorised Kygevvi on 3 November 2025

Marketing authorisations

FDA — authorised 3 November 2025

  • Application: NDA219792
  • Marketing authorisation holder: UCB INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Kygevvi, a new molecular entity, for marketing in the United States on 3 November 2025. The approval was granted to UCB INC, the marketing authorisation holder. The indication for Kygevvi was approved under the standard expedited pathway.

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FDA

  • Marketing authorisation holder: UCB INC
  • Status: approved

Kygevvi 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 Kygevvi approved in United States?

Yes. FDA authorised it on 3 November 2025; FDA has authorised it.

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

UCB INC holds the US marketing authorisation.