FDA Approves Pfizer's Fast Acting Migraine Drug Acquired Via $11B Biohaven Acquisition

  • The FDA has approved Pfizer Inc PFE acquired Biohaven's Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. 
  • In its pivotal Phase 3 study, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours post-dose. 
  • The pivotal study demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.
  • Pfizer added zavegepant and rimegepant to its kitty after acquiring Biohaven Pharmaceutical Company Ltd last year for $11.6 billion.
  • Rimegepant, sold as Nurtec ODT, is one of the other two CGRP migraine treatments approved by the FDA (it is also approved for preventing migraines).
  • The treatment expands Pfizer's migraine portfolio, including oral therapy for acute and preventive treatment.
  • Zavzpret is anticipated to be available in pharmacies in July 2023.
  • Angela Hwang, chief commercial officer and president of Pfizer's global biopharmaceuticals business, said the approval "marks a significant breakthrough,", particularly for people who "need freedom from pain and prefer alternative options to oral medications."
  • Pfizer/Biohaven is testing an oral form of zavegepant to prevent and treat migraines. The Phase 2/3 study is expected to conclude in July.
  • Price Action: PFE shares are up 0.18% at $39.53 premarket on the last check Friday.
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