ViiV’s Fostemsavir Loses EU Fast-Track Status
Potential New HIV Treatment Reverts To Standard Review
Viiv Healthcare's marketing application for fostemsavir started off being fast-tracked through the review process at the European Medicines Agency in January but is now being reviewed under standard timelines. The product is being developed for the treatment of adults with multidrug resistant HIV-1 infection.
You may also be interested in...
Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.
The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.