DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced that the U.S. Food and Drug
Administration (FDA) has approved a New Drug Application (NDA) for
UBRELVY™ (ubrogepant) for the acute treatment of migraine with or
without aura in adults. UBRELVY™ is the first and only
orally-administered calcitonin gene-related peptide (CGRP) receptor
antagonist (gepant) for the treatment of migraine attacks once they
start. Migraine is a neurological disease characterized by
intermittent migraine attacks with symptoms that are often
incapacitating. Migraine afflicts 31 million Americans and is the
third most common disease and second leading cause of disability
worldwide.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8663051-allergan-ubrelvy-acute-treatment-migraine-fda-approval/
"The FDA's approval of UBRELVY™, a new oral option that is
effective in the acute treatment of migraine attacks, is a
much-welcomed development for me and for many who care for
patients. I can offer my migraine patients a new treatment option
that may work for them," said Dr. Peter
Goadsby, Neurologist and Professor at King's College,
London, and University of California, San Francisco, and a paid
consultant for Allergan. "Perhaps even better, I am able to offer a
new sense of hope for my patients who struggle for relief from this
highly disabling problem."
In clinical trials supporting the FDA's approval,
UBRELVY™ provided quick pain relief for the majority of
migraine patients. UBRELVY™ also met co-primary endpoints of
freedom from pain and freedom from the most bothersome symptom
(nausea, hypersensitivity to light, or hypersensitivity to sound),
a recent, more stringent standard of efficacy the FDA set in 2018.
UBRELVY™ provided lasting relief up to 24 hours as well. UBRELVY™
works in a new way by blocking CGRP, a protein that is released
during a migraine attack, from binding to its receptors. It works
without constricting blood vessels, which some older treatments are
known to do. UBRELVY™ is non-narcotic, not scheduled, and does not
have addiction potential. It has been approved with two dose
strengths, 50 mg and 100 mg, and is specially designed so
healthcare providers can provide a personalized treatment approach
for appropriate patients.
"As someone living with migraine for 14 years, my life seems to
be on pause when I experience a migraine attack," said Kristin Molacek, UBRELVY™ clinical trial
patient. "During the clinical trial, my experience with UBRELVY™
was positive. It relieved the migraine symptoms that bothered me
the most without serious side effects. We have needed this type of
on-demand oral relief for a very long time, and I look forward to
having the ability to better manage my migraine attacks."
"We are extremely pleased that UBRELVY™ is now approved by the
FDA. As the first oral gepant, UBRELVY™ offers a new and different
type of acute treatment option for people living with the
debilitating pain and other symptoms of migraine," said
David Nicholson, EVP and Chief
R&D Officer, Allergan. "Its oral administration with two dose
strengths allows for treatment flexibility and relief when a
migraine attack occurs. As we continue to drive innovation in
migraine treatment, we are very proud to offer patients another
option, and we are confident that it will make a difference for
those in need. At Allergan, we believe that migraine patients
deserve access to all new medications for this debilitating
disease."
About UBRELVY™ (ubrogepant)
UBRELVY™
(ubrogepant) is a novel, highly potent, orally-administered
calcitonin gene-related peptide (CGRP) receptor antagonist
(gepant) for the acute treatment of migraine with or without aura
in adults that is an option for a wide range of patients who
experience migraine attacks. It works in a new way by blocking
CGRP, a protein released during a migraine attack, from binding to
its receptors. It works without constricting blood vessels, which
some older treatments are known to do. CGRP receptor antagonism is
a completely new mechanism of action for the acute treatment of
migraine.
The FDA approval for UBRELVY™ is based on four clinical studies
(ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002), which
demonstrated efficacy, safety and tolerability of
orally-administered UBRELVY™ in the acute treatment of migraine.
The two pivotal Phase 3 clinical trials (ACHIEVE I and ACHIEVE II)
established the safety and efficacy profile of UBRELVY™. Both 50 mg
and 100 mg dose strengths demonstrated significantly greater rates
of pain freedom and freedom from the most bothersome
migraine-associated symptom at two hours, compared with
placebo.
Nausea was the most common adverse event reported in 1.7-4.1% of
patients at various doses during the pivotal studies, compared to
1.6-2.0% of patients who received placebo. There were no serious
adverse events within 48 hours of a dose. Additionally, the safety
study (UBR-MD-04) reinforced the long-term safety and tolerability
of UBRELVY™ for both the 50 mg and 100 mg dose strengths. Our
research shows that UBRELVY™ was well tolerated with an adverse
event profile similar to placebo.
Visit www.ubrelvy.com for more information.
UBRELVY™ will be available in the first quarter of 2020.
About Migraine
Migraine is a neurological disease with episodic attacks defined by
symptoms such as headache pain, sensitivity to light and sound, and
nausea. Migraine is highly prevalent, affecting approximately 31
million Americans, and is associated with significant disability
leading to high personal, family, occupational, societal, and
economic burden. There has long been a need for new treatments for
migraine with improved benefit-risk profiles as compared to current
standard of care.
INDICATION
UBRELVYTM (ubrogepant) is indicated for the
acute treatment of migraine with or without aura in adults.
UBRELVY™ is not indicated for the preventive treatment of
migraine.
IMPORTANT SAFETY INFORMATION
Contraindication: Concomitant use of strong CYP3A4
inhibitors (e.g., ketoconazole, itraconazole,
clarithromycin).
Adverse Reactions: The most common adverse reactions were
nausea (4%) and somnolence (3%).
Please see link to full Prescribing
Information.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a global pharmaceutical leader focused on developing,
manufacturing and commercializing branded pharmaceutical, device,
biologic, surgical and regenerative medicine products for patients
around the world. Allergan markets a portfolio of leading brands
and best-in-class products primarily focused on four key
therapeutic areas including medical aesthetics, eye care, central
nervous system and gastroenterology. As part of its approach to
delivering innovation for better patient care, Allergan has built
one of the broadest pharmaceutical and device research and
development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
About Allergan Leadership in Migraine
Allergan, a leader in
the migraine space, markets BOTOX® (onabotulinumtoxinA),
the first FDA-approved, preventive treatment for adult Chronic
Migraine (approved 2010) and UBRELVY™ (ubrogepant), the
first FDA-approved oral calcitonin gene-related peptide (CGRP)
receptor antagonist (gepant), which is indicated for the acute
treatment of migraine with or without aura in adults. Allergan is
also advancing its migraine program with atogepant, an
investigational small molecule oral calcitonin gene-related peptide
(CGRP) receptor antagonist (gepant) specifically designed for the
prevention of migraine. Atogepant is currently in Phase 3
development.
About Allergan MIND™
As part of Allergan's ongoing commitment to innovating
and inspiring change in the migraine community, the company has
established a migraine franchise, Allergan MIND™ (Migraine:
Innovation, Navigation, Discovery), to drive progress and
unify its efforts as a worldwide leader in migraine. Allergan
MIND™ represents the company's vision and mission to continue
advancing science and improving the lives of people living with
migraine with treatments, education and support in the pursuit of
migraine freedom. This new migraine franchise serves as a center of
excellence and catalyst for advancing the dialogue and treatment
landscape in migraine, bringing together diverse stakeholders to
rally around the latest insights and developments that will impact
the future of migraine.
Forward-Looking Statement
Statements contained
in this press release that refer to future events or other
non-historical facts are forward-looking statements that reflect
Allergan's current perspective on existing trends and information
as of the date of this release. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated with
divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2019. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS: Allergan:
Investors:
Manisha
Narasimhan, PhD
(862) 261-7162
Media: Lisa Brown
(862) 261-7320
Julie Ciardiello
(732) 429-4909
View original
content:http://www.prnewswire.com/news-releases/allergan-receives-us-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults-300979082.html
SOURCE Allergan plc