Roche, PTC will now get an FDA de­ci­sion on their SMA drug in 6 months — fac­ing off with Bio­gen, No­var­tis

A ma­jor com­peti­tor to Bio­gen’s Spin­raza fran­chise could ar­rive as ear­ly as this com­ing May, as Roche and its biotech part­ner ob­tained a pri­or­i­ty re­view for ris­diplam.

FDA reg­u­la­tors will make a de­ci­sion on the spinal mus­cu­lar at­ro­phy drug by May 24, 2020, ac­cord­ing to PTC Ther­a­peu­tics, who is bag­ging $15 mil­lion in mile­stone pay­ment for the NDA fil­ing ac­cep­tance.

The move comes on the heels of topline da­ta from the Phase III SUN­FISH tri­al, in which ris­diplam met the pri­ma­ry end­point on change from base­line in the Mo­tor Func­tion Mea­sure 32 (MFM-32) scale af­ter one year of treat­ment, com­pared to place­bo. The re­sults con­firmed ear­li­er find­ings from part one of the study.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER