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

 
• By Sue Sutter

Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.

Pipes misaligned
The FDA statistical and clinical pharmacology teams' respective views on tofersen were not in alignment. • Source: Shutterstock

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