NEW HAVEN, Conn., Nov. 17, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven")
announced today that NURTEC® ODT (rimegepant) was approved by the
Kuwait 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, "Biohaven is committed to rapidly
expanding the availability of NURTEC ODT to patients around the
world, particularly in the Middle
East where migraine is a common disease and a leading cause
of disability. By expanding the market approval of NURTEC ODT in
the region, and leveraging our newly-announced strategic global
collaboration with Pfizer Inc., we are well-positioned to increase
access to NURTEC ODT to help a growing array of people living with
the burden of migraine."
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 Genpharm Services to pursue registration
approval of the NURTEC ODT dossier in Kuwait. The company has also received market
approval for NURTEC ODT in the Middle
East region from the Israeli Ministry of Health and the
United Arab Emirates Ministry of Health and Prevention.
Strategic collaboration with Pfizer for global
Biohaven recently announced a strategic collaboration with
Pfizer Inc. for the global commercialization of rimegepant
(marketed in the United States and
some ex-US regions as NURTEC ODT). Under the partnership, Pfizer
gains rights to commercialize rimegepant in markets outside the
U.S. upon approval. Biohaven will continue to commercialize NURTEC
ODT in the U.S. and remain responsible for further clinical
development of the rimegepant franchise. Closing of the license
agreements and equity purchase are contingent on completion of
review under applicable antitrust laws, including the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the
U.S. and equivalents outside the U.S., and other customary closing
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,
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
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
Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of its
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
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:
Pregnant/breast feeding: It is not known if NURTEC ODT can harm
an unborn baby or if it passes into breast milk.
Hepatic impairment: Avoid use of NURTEC ODT in persons with
severe hepatic impairment.
Renal impairment: Avoid use in patients with end-stage renal
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.
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.
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 and the
Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on November 9,
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.
Neuroinnovation is a trademark of Biohaven Pharmaceutical
Holding Company Ltd.
Chief Executive Officer
Sam Brown Inc.
View original content to download
SOURCE Biohaven Pharmaceutical Holding Company Ltd.