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FDA Approves Ampyra Despite Slight Responder Rate and Seizure Risk

This article was originally published in The Pink Sheet Daily

Executive Summary

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. 

Ampyra Seizure Warnings Strengthened Followed Continued Reports

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.”

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