Keeping Track: Neurology And Breakthroughs Stay In Spotlight As US FDA Approves Radicava, Imfinzi; TaiMed Submits Ibalizumab
The latest drug development news and highlights from our Performance Tracker.
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The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.
The Astellas-partnered drug did not reach statistical significance on any FORTITUDE-ALS endpoints, but clinically significant results over time justify a longer Phase III study that's likely to enroll ALS patients with a faster rate of disease progression.
Early engagement with US payers suggests openness to covering a liquid form of riluzole, because the tablet version is proven, but it's impossible to take for many ALS patients, says Italfarmaco subsidiary ITF Pharma.