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:
- 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
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
Vlad.Coric@biohavenpharma.com
NURTEC is a trademark of Biohaven Pharmaceutical Ireland
DAC.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.