Santhera starts Phase III DMD trial

Santhera Pharmaceuticals Holding AG (SIX:SANN) said it enrolled the first patient in its Phase III SIDEROS study of Raxone idebenone to treat Duchenne muscular dystrophy. The company hopes to include SIDEROS data, which are due in 2019, in a planned NDA.

In July, Santhera said FDA would not support the company's plan to submit an NDA for the candidate without data from SIDEROS (see BioCentury Extra, July 14). ...