U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine

NEW HAVEN, Conn., Oct. 14, 2020 /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 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.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "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.  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.

Robert Croop, M.D., Chief Development Officer – Neurology at Biohaven added, "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. 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.

Elyse Stock, M.D., Chief Medical Officer at Biohaven stated, "Unlike the injectable CGRP-targeting biologics, NURTEC ODT offers the potential for a convenient oral medication with dual benefits for both the acute and preventive treatment of migraine, requires no injection, and has a half-life of approximately 11 hours that allows immediate cessation of therapy in the event of pregnancy, nursing, hypersensitivity reaction, or adverse reactions. Thus, NURTEC ODT's safety and efficacy has the potential to address important unmet needs in the current landscape of preventive treatments of migraine."

About NURTEC ODT
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. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.

About NURTEC ODT sNDA Filing
The sNDA filing was based on the outcomes of a pivotal migraine preventive treatment trial of people with migraine (Study 305) as well as the rimegepant long-term, open-label safety study (Study 201) that supported the approval of NURTEC ODT for the acute treatment of migraine. Study 305 achieved its primary endpoint demonstrating a statistically significant reduction from baseline in monthly migraine days in people treated with rimegepant compared with placebo during the third month of treatment. Those receiving rimegepant 75 mg every-other-day (n=348) experienced a 4.3 day reduction from baseline in monthly migraine days, compared to a 3.5 day reduction in the placebo group (n=347; p<0.05). Importantly, 49.1% of the rimegepant group had at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month compared to 41.5% in the placebo group (p<0.05). People with migraine in this trial could continue in an ongoing 1-year open-label extension to receive rimegepant every-other-day and also as needed for acute treatment of a migraine attack.

The long-term safety study (201) assessed the safety and tolerability of NURTEC ODT with multiple doses used up to one year. The study evaluated 1,800 people, who used NURTEC ODT 75 mg up to one dose per day. The study included 1,131 people who were exposed to NURTEC ODT for at least six months, and 907 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.

If approved, NURTEC ODT will be the first and only CGRP-targeting therapy with indications for both preventive and acute treatment of migraine.

About CGRP Receptor Antagonism
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.

Indication
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use
NURTEC ODT is not indicated for the preventive treatment of migraine.

Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of its components.

Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy.  Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo).  Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.

Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP.  Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Use in Specific Populations:

1. Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.
   
   
2. Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.
   
   
3. Renal impairment: Avoid use in patients with end-stage renal disease. 

Please click here for full Prescribing information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4NURTEC.

Please click here for full Prescribing information and Patient Information.

About Biohaven
Biohaven is a 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 treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

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 that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: commercialization and sales of NURTEC ODT and the potential approval and commercialization of other product candidates, the effect of the ongoing COVID-19 pandemic on Biohaven, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings,  including the need for any REMS or Advisory Committee meetings, 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. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify forward-looking statements. 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 filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission on August 10, 2020. 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
Dr. Vlad Coric
Chief Executive Officer
[email protected]

NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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