BioCentury
ARTICLE | Clinical News

Catena idebenone regulatory update

April 13, 2015 7:00 AM UTC

FDA granted Fast Track designation to Catena idebenone from Santhera to treat Duchenne muscular dystrophy (DMD). The company plans to hold a pre-NDA meeting with FDA for the short-chain benzoquinone in the coming weeks. Catena met the primary endpoint in the Phase III DELOS trial in DMD, for which the product also has Orphan Drug designation in the U.S. and EU (see BioCentury, May 19, 2014 & May 26, 2014). ...