At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion

The US FDA Office of Neuroscience’s presentation approach at the recent advisory committee review of Biogen, Inc. and Ionis Pharmaceuticals, Inc.’s Qalsody (tofersen) for SOD1 amyotrophic lateral sclerosis appears to have reflected the hard lessons learned from the November 2020 Aduhelm (aducanumab-avwa) panel meeting.

In a situation where there was clearly internal disagreement among review disciplines – specifically, the statistical team on one side, and the clinical pharmacology team on the other – the agency’s presentation at the 22 March meeting of the Peripheral and Central Nervous