Santhera debuts Duchenne Expanded Access Program in USA

Swiss drugmaker Santhera Pharmaceutical (SIX: SANN) has launched an Expanded Access Program (EAP) in the USA, referred to as BreatheDMD with idebenone for patients with Duchenne muscular dystrophy.

The firm’s request for expedited regulatory treatment with Raxone/Catena (idebenone) in the USA was rejected by the FDA in late 2016. Last month Santhera said it anticipated a negative opinion for Raxone from the European Medicines Agency.

Through the BreatheDMD program, eligible patients in the USA with DMD who are 10 years and older and in respiratory function decline, can obtain access to investigational idebenone, at no cost, through a growing network of research centers across the USA.