Radicava US Approval Boost To Mitsubishi As Sales Decline
The arrival of the first drug for ALS in more than 20 years in the US will also be a boost to its originator Mitsubishi Tanabe's American ambitions.
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Amylyx has raised just $75m to date, but that was enough to develop AMX0035 through a Phase II/III trial in which the drug slowed the progression of amyotrophic lateral sclerosis versus placebo.
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.
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.