🇺🇸 Roctavian in United States

Roctavian (VALOCTOCOGENE ROXAPARVOVEC) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Roctavian in other countries

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

Other Rare Disease approved in United States

Frequently asked questions

Is Roctavian approved in United States?

Yes. FDA has authorised it.

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

BioMarin International Limited is the originator. The local marketing authorisation holder may differ — check the official source linked above.