FDA accepts NDA for vamorolone in Duchenne muscular dystrophy.- Santhera Pharmaceuticals + ReveraGen BioPharma, Inc.,
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc., announce that the FDA has accepted the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing
The FDA has set October 26, 2023, as the Prescription Drug User Fee Act (PDUFA) target action date.
The PDUFA date is the target date for the FDA to complete its review of the NDA. Furthermore, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss the application. Subject to approval, Santhera plans to launch vamorolone in the U.S. in Q4-2023.
The NDA submission for vamorolone was supported by clinical data from the positive pivotal Phase IIb VISION-DMD study which met the primary endpoint with statistical significance over placebo. The data package also included data from four open-label studies (including extension) in which vamorolone was administered at doses between 2 and 6 mg/kg/day for a total treatment period of up to 30 months.
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