ARTICLE | Company News

CHMP issues negative opinions

September 15, 2017 11:51 PM UTC

On Friday, EMA's CHMP issued negative opinions for a number of products, including Duchenne muscular dystrophy candidate Raxone idebenone (SNT-MC17) from Santhera Pharmaceuticals Holding AG (SIX:SANN). CHMP also said Bristol-Myers Squibb Co. (NYSE:BMY) withdrew an MAA seeking to add liver cancer to the label for PD-1 mAb Opdivo nivolumab.

CHMP recommended against approving an MAA for Raxone to slow down the worsening of breathing function in DMD patients who are not taking corticosteroids. CHMP said the data Santhera provided were insufficient because while Raxone did improve peak expiratory flow compared to placebo, the data showed "no clear improvement in other indicators of breathing function or in muscle strength, motor function or quality of life." The committee also said it had concerns about the way the study was conducted and analyzed, but did not provide details. Santhera said it plans to appeal the recommendation. ...