🇺🇸 Wayrilz in United States

FDA authorised Wayrilz on 29 August 2025

Marketing authorisations

FDA — authorised 29 August 2025

Application: NDA219685
Marketing authorisation holder: GENZYME CORP
Local brand name: WAYRILZ
Indication: TABLET — ORAL
Status: approved

The FDA approved Wayrilz, a new molecular entity, on August 29, 2025, under the standard expedited pathway. GENZYME CORP is the marketing authorisation holder. The approval was granted for the treatment of a specific medical condition, but the exact indication is not specified in the available data.

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FDA

Marketing authorisation holder: GENZYME CORP
Status: approved

Wayrilz 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 Wayrilz approved in United States?

Yes. FDA authorised it on 29 August 2025; FDA has authorised it.

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

GENZYME CORP holds the US marketing authorisation.