FDA Accepts sNDA Of NURTEC ODT for Preventive Treatment of Migraine

Biohaven Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.

"Patients with migraine deserve the simplicity of managing their disease with a single medication that alleviates acute episodes and also works to prevent future attacks. Our goal with the NURTEC ODT development program has been to offer a fast acting, quick-dissolve oral tablet with "dual-acting" properties --acute and preventive-- to treat migraine across its full spectrum,” Vlad Coric, M.D., Chief Executive Officer of Biohaven said. “We believe that the ease of use associated with a single oral medication will benefit people with migraine so that they can take back their days, and also provides the health care system with a cost-effective approach as opposed to paying for two separate drugs for acute and preventive treatment."

Migraine is a debilitating neurological disease that affects approximately 15% of the adult population in the US, comprising nearly 40 million adults. Migraine ranks as the third most prevalent disease worldwide, and the seventh highest specific cause of disability worldwide. It is a disabling and recurrent disease characterized by attacks lasting 4 to 72 hours with multiple symptoms, often including: pulsating, unilateral headaches of moderate to severe pain intensity that can be associated with nausea and/or vomiting, sensitivity to light (photophobia) and sound (phonophobia), aggravated by or causing avoidance of routine physical activity, and may occur with or without aura.

"NURTEC ODT's broad range of clinical activity from acute to preventive properties potentially marks a paradigm shift in the treatment of migraine. The magnitude of treatment effect with NURTEC ODT along with its favorable safety and tolerability profile in our clinical trials suggest that it could be a best-in class oral therapy for both preventive and acute treatment of migraine,” Robert Croop, M.D., Chief Development Officer – Neurology at Biohaven said. “Additionally, the safety profile of NURTEC in our prevention trial is consistent with the patient experience in the acute indication and unlike other CGRP targeting agents for prevention, NURTEC did not show a signal for constipation as a significant adverse effect as a preventive treatment."

NURTEC ODT 75 mg was launched in March 2020 for the acute treatment of migraine, and is the first and only CGRP receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action. Biohaven also reported positive results from its pivotal study in prevention of migraine that formed the basis of the company's sNDA filing submitted to the U.S. FDA. The prevention trial showed that migraine patients who received rimegepant 75 mg, administered every other day, experienced a statistically significant 4.3 day reduction from baseline in monthly migraine days.

NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide.