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 PharmaHolding 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
About NURTEC ODT sNDA Filing
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
Limitations of Use
Important Safety Information
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:
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.
NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.
Company Codes: NYSE:BHVN