- If approved, zavegepant nasal spray would be the only
FDA-approved CGRP receptor antagonist in an intranasal formulation,
giving patients a new treatment option that provides ultra-rapid
pain relief in as little as 15 minutes that lasts through 48 hours
after a single dose
- Zavegepant nasal spray may provide an important alternative
for patients who need a quick onset of action or those who cannot
take oral treatments due to nausea and vomiting at the time of
migraine onset
NEW HAVEN, Conn. ,
May 23,
2022 /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 a New
Drug Application (NDA) for zavegepant nasal spray, the only small
molecule calcitonin gene-related peptide (CGRP) receptor antagonist
in an intranasal formulation, for the acute treatment of migraine
in adults. The Prescription Drug User Fee Act (PDUFA) goal date for
completion of the FDA review of the NDA is set for 1Q2023.
Vlad Coric, M.D., Chief Executive
Officer and Chairman of Biohaven, commented, "People with migraine
want an acute treatment that provides fast, lasting relief from the
debilitating symptoms of this disease. If approved, zavegepant
would provide a new treatment option for patients who need
ultra-rapid relief, in as early as 15 minutes, and for those that
experience nausea or vomiting and need a non-oral treatment option.
We have generated robust data from two intranasal zavegepant
pivotal trials that were submitted with our NDA and look forward to
bringing this new treatment option to people suffering from
migraine."
The NDA for zavegepant was based on two pivotal double-blind,
placebo-controlled studies that established the efficacy,
tolerability and safety profile of zavegepant for the acute
treatment of migraine. In the pivotal studies, zavegepant was
statistically superior to placebo on the coprimary regulatory
endpoints of superiority to placebo at 2 hours for pain freedom and
freedom from the migraine-associated most bothersome symptom
(MBS). In the trials, patients identified their most
bothersome symptom other than pain from a list comprised of nausea,
heightened sensitivity to light (photophobia) and heightened
sensitivity to sound (phonophobia). In the Phase 3
pivotal trial, zavegepant showed broad efficacy by demonstrating
statistically significant superiority to placebo across a total of
15 prespecified primary and secondary outcome measures, including
multiple ultra-rapid onset endpoints (e.g., 15 minute pain relief
and return to normal function in 30 minutes) and multiple durable
efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom
and sustained pain relief).
Richard B. Lipton, M.D.,
Professor and Vice Chair of Neurology at the Albert Einstein
College of Medicine and Director of the Montefiore Headache Center,
commented, "Many patients with migraine need treatments other than
pills for at least some of their attacks. Swallowing a pill may
make nausea worse and if the patient vomits, medication cannot be
absorbed. Nasal sprays are a favored option to tablets in
many situations. In addition, many patients dissatisfied with their
current acute treatments want faster relief so they can get back to
their plans without missing life's important moments. Zavegepant
nasal spray will be an important option for patients seeking
nonoral therapies and faster relief. Though head to head
studies are lacking, relative to triptan nasal sprays, zavegepant
should provide favorable safety and tolerability, lack of
cardiovascular contraindications and precautions and a reduced risk
of medication overuse."
Elyse Stock, M.D., Chief Medical
Officer, commented, "In addition to providing new treatment options
for everyday heroes at home, work and school, many of the 40
million people in the US with migraine hold high-intensity jobs.
When migraine strikes, they need a fast-acting treatment option
that enables them to quickly get back to work and keep on working.
The zavegepant profile of ultra-rapid 15 minute onset and durable
efficacy through 48 hours with a single dose is uniquely well
suited to serve people with migraine."
About Zavegepant
Zavegepant is a third generation,
high affinity, selective and structurally unique, small molecule
CGRP receptor antagonist from Biohaven's NOJECTION® Migraine
Platform and the only CGRP receptor antagonist in clinical
development with both intranasal and oral formulations. The
efficacy and safety profile of zavegepant for the acute treatment
of migraine has now been established across two randomized
controlled trials: a Phase 3 trial and a Phase 2/3 trial. The
co-primary endpoints achieved in both studies are consistent with
regulatory guidance from the FDA and provide the basis for the NDA
submission to the FDA.
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 often
associated with nausea or vomiting, and/or sensitivity to sound
(phonophobia) and sensitivity to light (photophobia). There is a
significant unmet need for new acute and preventive treatments as
more than 90 percent of people with migraine are unable to work or
function normally during an attack.
About CGRP Receptor Antagonism
Small molecule CGRP
receptor antagonists represent a novel class of drugs for the
treatment of migraine. For acute treatment, this unique mode of
action offers an alternative to other agents, including those
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 global 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 (EMA-approved as Vydura® for
the acute treatment of migraine with or without aura, and
prophylaxis of episodic migraine in adults who have at least four
migraine attacks per month) and a broad pipeline of late-stage
product candidates across five distinct mechanistic platforms: CGRP
receptor antagonism for the acute and preventive treatment of
migraine and other CGRP-mediated diseases; glutamate modulation for
obsessive-compulsive disorder and spinocerebellar ataxia;
myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis;
Kv7 ion channel activators for focal epilepsy and neuronal
hyperexcitability, and myostatin inhibition for neuromuscular
diseases. More information about Biohaven is available
at www.biohavenpharma.com.
NURTEC, NURTEC ODT and VYDURA are registered trademarks of
Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION
are trademarks of Biohaven Pharmaceutical Holding Company Ltd.
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 ability to commercialize zavegepant nasal
spray delays or problems in the supply or manufacture of commercial
product, 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 with the FDA, the timing and outcome of 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 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.
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
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.