The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned.
Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so, the review time will be cut from ten to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.
