Roche: gene therapy gets FDA fast-track designation
(CercleFinance.com) - The US Food and Drug Administration has decided that Sarepta's SRP-9001 gene transfer therapy to treat Duchenne muscular dystrophy deserves a fast-track designation, Roche said on Friday.
Sarepta's SRP-9001 has been designed to deliver an encoding gene to muscle tissue for the production of micro-dystrophin protein to provide functional improvement in patients with this rare disease.
Last year, the company struck a licensing deal granting Roche the exclusive right to launch and commercialize this gene therapy outside the United States.
FDA's fast-track designation is a process designed to facilitate the review of drugs that treat serious conditions and fill unmet medical needs.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
Sarepta's SRP-9001 has been designed to deliver an encoding gene to muscle tissue for the production of micro-dystrophin protein to provide functional improvement in patients with this rare disease.
Last year, the company struck a licensing deal granting Roche the exclusive right to launch and commercialize this gene therapy outside the United States.
FDA's fast-track designation is a process designed to facilitate the review of drugs that treat serious conditions and fill unmet medical needs.
Copyright (c) 2020 CercleFinance.com. All rights reserved.