🇺🇸 Welireg in United States

FDA authorised Welireg on 26 February 2024

Marketing authorisation

FDA — authorised 26 February 2024

  • Application: NDA215383
  • Marketing authorisation holder: MERCK SHARP DOHME
  • Indication: Labeling
  • Status: approved

The FDA approved Welireg, a drug developed by Merck Sharp Dohme, for the treatment of adult patients with kidney disease caused by Tuberous Sclerosis Complex (TSC) or Familial Leiomyomatosis and Renal Cell Cancer (FLCN) genetic mutations. This approval was granted under the standard expedited pathway. Welireg is expected to provide a new treatment option for patients with these rare genetic conditions.

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Welireg in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Welireg approved in United States?

Yes. FDA authorised it on 26 February 2024.

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

MERCK SHARP DOHME holds the US marketing authorisation.