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Wednesday, December 16, 2020

Biohaven's rimegepant effective in migraine prevention

 

  • The Lancet has published Biohaven Pharmaceutical's (NYSE:BHVN) positive results from a Phase 3 clinical trial of rimegepant for the preventive treatment of migraine in adults.
  • These data show rimegepant was superior to placebo on the primary endpoint of change in mean number of migraine days.
  • Rimegepant showed a −4.3 day reduction in monthly migraine days during the prespecified treatment period.
  • Rimegepant was also superior to placebo on multiple secondary endpoints. Notably, 49% of the rimegepant group had at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month compared to 41% in the placebo group in weeks 9 through 12.
  • Additionally, the incidence of adverse events was similar with rimegepant and placebo (36% vs 36%).
  • The FDA has accepted Biohaven's sNDA for NURTEC ODT for migraine prevention with PDUFA goal date in 2Q2021.
  • Rimegepant is the first and only CGRP targeting medication in development to show dual efficacy for both the acute and preventive treatment of migraine.
  • The Lancet full article is available online.
  • https://seekingalpha.com/news/3644824-biohavens-rimegepant-effective-in-migraine-prevention

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