FDA accepts for review an NDA for intranasal zavegepant for the acute treatment of migraine.
Biohaven Pharmaceutical Holding Company Ltd. announced that the FDA has filed and accepted for review a New Drug Application (NDA) for zavegepant nasal spray, the only small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in an intranasal formulation, for the acute treatment of migraine in adults.
The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the NDA is set for 1Q 2023.
Vlad Coric, M.D., Chief Executive Officer and Chairman of Biohaven, commented, "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."
The NDA for zavegepant was based on two pivotal double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profile of zavegepant for the acute treatment of migraine. In the pivotal studies, zavegepant was statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at 2 hours for pain freedom and freedom from the migraine-associated most bothersome symptom (MBS).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins