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.