According to Biohaven Pharmaceuticals, the FDA has accepted the company’s NDA for its zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine and has set a PDUFA goal date in the first quarter of 2023. In December 2019, Biohaven announced positive results from a Phase 2/3 pivotal trial of the nasal spray in migraine patients, and in December 2021, the company announced that a Phase 3 trial of intranasal zavegepant demonstrated statistical superiority to placebo across 15 endpoints.
The company recently announced that it was being acquired by Pfizer, which had already acquired rights to the zavegepant nasal spray outside of the US earlier this year; Biohaven had retained the US rights. Royalty Pharma had provided funding for Phase 3 clinical development of zavegepant, which was formerly called “vazegepant.”
Biohaven CEO and Chairman Vlad Coric said, “People with migraine want an acute treatment that provides fast, lasting relief from the debilitating symptoms of this disease. If approved, zavegepant would provide a new treatment option for patients who need ultra-rapid relief, in as early as 15 minutes, and for those that experience nausea or vomiting and need a non-oral treatment option. We have generated robust data from two intranasal zavegepant pivotal trials that were submitted with our NDA and look forward to bringing this new treatment option to people suffering from migraine.”
Chief Medical Officer Elyse Stock added, “In addition to providing new treatment options for everyday heroes at home, work and school, many of the 40 million people in the US with migraine hold high-intensity jobs. When migraine strikes, they need a fast-acting treatment option that enables them to quickly get back to work and keep on working. The zavegepant profile of ultra-rapid 15 minute onset and durable efficacy through 48 hours with a single dose is uniquely well suited to serve people with migraine.”
Read the Biohaven Pharmaceuticals press release.
