- Insurance Coverage of Nurtec ODT Now Totals 96 Percent of
Commercial Lives or Approximately 255 Million Lives Covered in All
Channels
- Nurtec ODT Label Expanded to include Lactation Data in the
Prescribing and Patient Information for Breastfeeding Mothers
NEW
HAVEN, Conn., April 14,
2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN) today announced two updates regarding
Nurtec® ODT (rimegepant), the only FDA-approved medication to both
treat and prevent migraine attacks in adults.
Achievement of Broader Commercial Insurance
Coverage
Biohaven has secured additional commercial
insurance coverage for Nurtec ODT starting in April 2022 that expands the total number of
commercial lives covered to 96 percent or approximately 255 million
people via all channels.
"Ensuring that people with migraine can have access to Nurtec
ODT is the first priority for Biohaven," said Chris Barrett, SVP, Managed Markets and
Government Affairs. "We hear from patients daily about the impact
that Nurtec ODT has on their lives and the transformative effect it
has in getting them back to what's important to them. We continue
to focus on ways to enhance how people with migraine can easily
access Nurtec ODT."
Updated Label to Include Data from Breastfeeding
Women
The U.S. Food and Drug Administration has approved a
label amendment of the Nurtec ODT (rimegepant) Prescribing and
Patient Information to include clinical lactation data in the Use
in Specific Populations section as it relates to women who are
breastfeeding.
"Migraine is the most common cause of disability among women of
reproductive age and this expanded label offers treating physicians
and patients a migraine medication that can be further considered
for those women who are breastfeeding," said Elyse Stock, MD, Chief Medical Officer. "Our
data showed that excretion of rimegepant into human milk is very
low and rimegepant was well tolerated by lactating women, offering
them an option for the acute and preventive treatment of
migraine."
The label amendment was approved based on data from a Phase 1,
single-center, open-label study evaluating the excretion of a
single dose of rimegepant 75 mg in the human milk of healthy
lactating women, recently published in the peer-reviewed journal,
Breastfeeding Medicine, the official journal of the Academy
of Breastfeeding Medicine.
Migraine affects more than 30 million women in America and
is the most common cause of disability among women of reproductive
age (15 – 49 years).1,2 Often
for women with migraine, attacks may subside during pregnancy but
resume within 4 weeks of childbirth.3 Given a lack of
science-based information about migraine medication for nursing
mothers, women are often apprehensive about taking their migraine
medications while breastfeeding.
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 with or without aura and the preventive
treatment of episodic 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. For more information
about Nurtec ODT, visit www.nurtec.com.
Rimegepant is available as Nurtec® ODT in the United
States for the acute and preventive treatment of migraine in
adults. Biohaven and Pfizer Inc. recently announced a positive
opinion by the Committee for Medicinal Products for Human Use of
the European Medicines Agency recommending the marketing
authorization for rimegepant 75 mg for the acute and preventive
treatment of migraine. If approved, the trade name will be Vydura™
in the European Union.
Indication
NURTEC ODT orally disintegrating tablets is
a prescription medicine that is used to treat migraine in adults.
It is for the acute treatment of migraine attacks with or without
aura and the preventive treatment of episodic migraine. It is not
known if NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT
if you are allergic to NURTEC ODT (rimegepant) or any of its
ingredients. Before you take NURTEC ODT, tell your healthcare
provider (HCP) about all your medical conditions, including if
you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
NURTEC ODT may cause serious side effects including allergic
reactions, trouble breathing and rash. This can happen days after
you take NURTEC ODT. Call your HCP or get emergency help right away
if you have swelling of the face, mouth, tongue, or throat or
trouble breathing. This occurred in less than 1% of patients
treated with NURTEC ODT.
The most common side effects of NURTEC ODT were nausea (2.7%)
and stomach pain/indigestion (2.4%). These are not the only
possible side effects of NURTEC ODT. Tell your HCP if you have any
side effects.
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.
See full Prescribing Information and Patient
Information.
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 that can
be associated with nausea or vomiting, and/or sensitivity to sound
(phonophobia) and sensitivity to light (photophobia). There is a
significant unmet need for new treatments as more than 90 percent
of people with migraine are unable to work or function normally
during an attack.
CGRP Receptor Antagonism
Small molecule CGRP receptor
antagonists represent a novel class of drugs for the treatment of
migraine. CGRP receptor antagonists work by reversibly blocking
CGRP receptors, thereby inhibiting the biologic activity of the
CGRP neuropeptide. For acute treatment, this unique mode of action
potentially offers an alternative to other 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. 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 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 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,
and spinocerebellar ataxia; and MPO inhibition for amyotrophic
lateral sclerosis; Kv7 Ion Channel Activators (Kv7), and Myostatin.
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 regarding the future
development, timing and potential marketing approval and
commercialization of NURTEC ODT (rimegepant), Vydura™ or
rimegepant. 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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of
Biohaven Pharmaceutical Holding Company Ltd.
Biohaven Contact
Jennifer
Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741
Media Contact
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
1. GBD 2019 Diseases
and Injuries Collaborators. Global burden of 369 diseases and
injuries in 204 countries and territories, 1990–2019: A systematic
analysis for the Global Burden of Disease Study
2019. Lancet 2020;396:1204–1222.
2. GBD 2016 Headache
Collaborators. Global, regional, and national burden of
migraine and tension-type headache, 1990–2016: A systematic
analysis for the Global Burden of Disease Study
2016. Lancet Neurol 2018;17:954–976.
3. Sances G,
Granella F, Nappi RE, et al. Course of migraine during
pregnancy and postpartum: A prospective
study. Cephalalgia 2003;23:197–205.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.