Posted by Michael Wonder on 08 Apr 2020
Genentech provides regulatory update on risdiplam for the treatment of spinal muscular atrophy
7 April 2020 - U.S. FDA extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2.
Genentech announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for its review of the new drug application of risdiplam with a decision expected by 24 August 2020.
The extension is a result of the recent submission of additional data by Genentech, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA.
