ARTICLE | Clinical News

CHMP re-examining negative opinion for Santhera's Raxone in DMD

November 30, 2017 11:22 PM UTC

In October, EMA's CHMP said it would re-examine its September recommendation against approval of Raxone idebenone (SNT-MC17) from Santhera Pharmaceuticals Holding AG (SIX:SANN) to slow the worsening of breathing function in Duchenne muscular dystrophy (DMD) patients.

CHMP recommended against expanding the drug's label on Sept. 14 after reviewing data from a trial of 64 DMD patients who were not on corticosteroids. The committee said Raxone improved peak expiratory flow compared to placebo, but showed "no clear improvement in other indicators of breathing function or in muscle strength, motor function or quality of life." It also expressed concerns about how the study was conducted and analyzed (see BioCentury, Sept. 22)...