🇺🇸 Journavx in United States

FDA authorised Journavx on 30 January 2025

Marketing authorisations

FDA — authorised 30 January 2025

Application: NDA219209
Marketing authorisation holder: VERTEX PHARMS INC
Local brand name: JOURNAVX
Indication: TABLET — ORAL
Status: approved

The FDA granted marketing authorisation to Journavx, a drug developed by VERTEX PHARMS INC, on 23 January 2026. The marketing authorisation was granted under the standard expedited pathway. The approved indication for Journavx is for labeling.

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FDA

Marketing authorisation holder: VERTEX PHARMS INC
Status: approved

Journavx in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Journavx approved in United States?

Yes. FDA authorised it on 30 January 2025; FDA has authorised it.

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

VERTEX PHARMS INC holds the US marketing authorisation.