FDA Approves Ampyra Despite Slight Responder Rate and Seizure Risk
This article was originally published in The Pink Sheet Daily
FDA approved Ampyra extended release tablets with the novel indication of improvement in walking ability in adults with multiple sclerosis.
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Other multiple sclerosis contenders – including Sanofi's Lemtrada, Acorda's Ampyra, and Merck KgAA's cladribine – have also been RTFed. Question now for Celgene is how long the delay will be.
The seizure risk for Acorda’s multiple sclerosis drug was already known, but an FDA MedWatch Alert based on post-market adverse event reports says, “the majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.”
MS drug spending is skyrocketing due to premium-priced new drugs and defensive price hikes across the category, making the therapeutic area a management priority for payers. Insurers are largely relying on aggressive contracting with manufacturers to manage the category, but new launches are unlikely to secure preferred formulary placement without comparative safety and efficacy data.