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Biotech Stocks Facing FDA Decision In April 2021

Biohaven Pharma
Biohaven Pharma

Biohaven Pharmaceutical Holding Company Ltd. (BHVN) has sought to expand the label of Nurtec ODT as a preventive treatment of migraine, and a regulatory decision is expected in the second quarter of 2021.

Nurtec ODT 75mg (orally disintegrating tablet) is a prescription medicine that is already approved for the acute treatment of migraine attacks with or without aura in adults. Approved in March 2020, Nurtec ODT raked in net product revenue of $63.6 million last year.

Blocking calcitonin gene-related peptide (CGRP) has emerged as a possible mechanism for prevention of migraine attack. Nurtec ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide.

In a prevention trial, migraine patients who received Nurtec ODT 75 mg, administered every other day, experienced a statistically significant 4.3 day reduction from baseline in monthly migraine days.

Aimovig, co-developed by Novartis and Amgen, Teva's Ajovy, Eli Lilly's Emgality and Allergan's Ubrelvy are approved CGRP inhibitors for migraine - the same class of drugs to which Nurtec ODT also belongs to.

BHVN closed Friday’s (Mar.26, 2021) trading at $66.55, down 1.23%.