Biohaven's NURTEC® ODT Approved In Israel For Acute Treatment Of Migraine

Rhea-AI Summary

Biohaven Pharmaceutical (NYSE: BHVN) announced that the Israeli Ministry of Health approved NURTEC® ODT (rimegepant) for the acute treatment of migraine in adults, marking its first regulatory approval outside the U.S. This fast-acting, orally disintegrating tablet offers pain relief within one hour and sustained efficacy lasting up to two days. The approval was achieved through a strategic partnership with Medison Pharma, enhancing access for migraine patients in Israel. NURTEC ODT is not indicated for preventive treatment or for patients with severe renal or hepatic impairment.

Positive

• First regulatory approval of NURTEC ODT outside the U.S.
• Rapid pain relief within one hour with effects lasting up to two days.
• Strategic partnership with Medison Pharma to enhance market access.

Negative

• NURTEC ODT is not indicated for preventive treatment of migraines.
• Not suitable for patients with severe renal or hepatic impairment.

NEW HAVEN, Conn., March 10, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma announced today that NURTEC® ODT (rimegepant) was approved by the Israeli Ministry of Health for the acute treatment of migraine with and without aura in adults. NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) approved for the acute treatment of migraine.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "We are excited about this first regulatory approval of NURTEC ODT outside of the United States. Approval of NURTEC ODT in Israel is an important step towards our goal of helping patients worldwide suffering from migraine and the strategic partnership with Medison Pharma will allow us to quickly expand access to NURTEC ODT."

A single quick-dissolving tablet of NURTEC ODT can provide fast pain relief and return patients to normal function within one hour, and deliver sustained efficacy that lasts up to 2 days after a single dose for many patients. NURTEC ODT disperses almost instantly in a person's mouth without the need for water, offering people with migraine a convenient, discreet way to take their medication anytime and anywhere they need it. NURTEC ODT is not indicated for the preventive treatment of migraine. Biohaven partnered with Medison Pharma to pursue regulatory approval of the NURTEC ODT dossier in Israel. 

Meir Jakobsohn, Founder and CEO, Medison Pharma commented, "The approval of NURTEC ODT in Israel is the result of our companies' shared efforts and joint commitment to providing access to breakthrough therapies that improve the lives of migraine patients."

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.

The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). 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.

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 Medison
Medison is one of the world's largest commercial partners of leading global biotech companies, providing the complete spectrum of integrated services for international companies looking to enter or expand their presence in Israel, Canada and CEE markets. Medison operates a corporate venture arm with a dedicated research and evaluation team boasting deep scientific and commercial backgrounds. Medison also operates a scouting program to cater its partners and is an active investor in life science projects around drug development and digital health.

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 MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-looking Statement
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, 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 and filings with the FDA, the timing and outcome of expected 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 the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. 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.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.

Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine-301244414.html

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

FAQ

What is the significance of NURTEC ODT's approval in Israel for BHVN?

The approval represents Biohaven's first regulatory success outside the U.S., potentially increasing market share in the migraine treatment sector.

When was NURTEC ODT approved by the Israeli Ministry of Health?

NURTEC ODT was approved on March 10, 2021.

How does NURTEC ODT work for migraine treatment?

NURTEC ODT is a CGRP receptor antagonist that blocks the neuropeptide CGRP, which plays a role in migraine pathophysiology.

What are the advantages of using NURTEC ODT?

NURTEC ODT provides rapid pain relief and sustained efficacy, with the convenience of a quick-dissolving tablet that doesn't require water.

Is there any indication of NURTEC ODT for migraine prevention?

No, NURTEC ODT is specifically indicated for acute treatment only, not for preventive use.