US FDA Accepts for Review Biohaven's New Drug Application (NDA) Filing of Intranasal Zavegepant for the…

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05/23/2022

US FDA Accepts for Review Biohaven's New Drug Application (NDA) Filing of Intranasal Zavegepant for the Acute Treatment of Migraine

• If approved, zavegepant nasal spray would be the only FDA-approved CGRP receptor antagonist in an intranasal formulation, giving patients a new treatment option that provides ultra-rapid pain relief in as little as 15 minutes that lasts through 48 hours after a single dose
• Zavegepant nasal spray may provide an important alternative for patients who need a quick onset of action or those who cannot take oral treatments due to nausea and vomiting at the time of migraine onset

NEW HAVEN, Conn. , May 23, 2022/PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the U.S. Food and Drug Administration (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 1Q2023.

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). In the trials, patients identified their most bothersome symptom other than pain from a list comprised of nausea, heightened sensitivity to light (photophobia) and heightened sensitivity to sound (phonophobia). In the Phase 3 pivotal trial, zavegepant showed broad efficacy by demonstrating statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures, including multiple ultra-rapid onset endpoints (e.g., 15 minute pain relief and return to normal function in 30 minutes) and multiple durable efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom and sustained pain relief).

Richard B. Lipton, M.D., Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Director of the Montefiore Headache Center, commented, "Many patients with migraine need treatments other than pills for at least some of their attacks. Swallowing a pill may make nausea worse and if the patient vomits, medication cannot be absorbed. Nasal sprays are a favored option to tablets in many situations. In addition, many patients dissatisfied with their current acute treatments want faster relief so they can get back to their plans without missing life's important moments. Zavegepant nasal spray will be an important option for patients seeking nonoral therapies and faster relief. Though head to head studies are lacking, relative to triptan nasal sprays, zavegepant should provide favorable safety and tolerability, lack of cardiovascular contraindications and precautions and a reduced risk of medication overuse."

Elyse Stock, M.D., Chief Medical Officer, commented, "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."

About Zavegepant
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of zavegepant for the acute treatment of migraine has now been established across two randomized controlled trials: a Phase 3 trial and a Phase 2/3 trial. The co-primary endpoints achieved in both studies are consistent with regulatory guidance from the FDA and provide the basis for the NDA submission to the FDA.

About Migraine
Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute and preventive treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.

About CGRP Receptor Antagonism
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. For acute treatment, this unique mode of action offers an alternative to other agents, including those patients who have contraindications to the use of triptans or who have a poor response to triptans or are intolerant to them. CGRP signal-blocking therapies have not been associated with medication overuse headache (MOH) or rebound headaches which limits the clinical utility of other acute treatments due to increases in migraine attacks that result from frequent use.

About Biohaven
Biohaven is a global commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved Nurtec® ODT (rimegepant) for the acute and preventive treatment of migraine (EMA-approved as Vydura® for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.

NURTEC, NURTEC ODT and VYDURA are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION are trademarks of Biohaven Pharmaceutical Holding Company Ltd.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements regarding the ability to commercialize zavegepant nasal spray delays or problems in the supply or manufacture of commercial product, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions with the FDA, the timing and outcome of regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on February 25, 2022, and Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Biohaven Contact
Jennifer Porcelli
Vice President, Investor Relations
[email protected]
201-248-0741

Media Contact
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.