FDA Approves Pfizer's Fast Acting Migraine Drug Acquired Via $11B Biohaven Acquisition - Pfizer (NYSE:PFE)

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.