LAVAL, Quebec, July 19, 2016 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced that the Dermatologic and Ophthalmic Drugs Advisory
Committee appointed by the U.S. Food and Drug Administration (FDA)
has voted by a margin of 18 to 0 for the approval of brodalumab
injection, 210 mg, for adult patients with moderate-to-severe
plaque psoriasis with conditions related to product labeling and
post-marketing/risk management obligations.
The committee's recommendation will be considered by the FDA in
its review of the Biologics License Applications (BLA) for
brodalumab, a monoclonal antibody that targets the IL-17
receptor. As previously announced, the FDA assigned a
Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
"The positive recommendation by the FDA's advisory committee
represents an important milestone toward our goal of delivering
brodalumab to patients who suffer from moderate-to-severe plaque
psoriasis," said Joseph C. Papa,
chairman and chief executive officer. "Brodalumab has the
potential to improve the lives of many patients suffering from this
chronic, debilitating disease, and we greatly appreciated the
opportunity to present our body of evidence to the panel. We
look forward to working collaboratively with the FDA as it
continues its review process."
"Brodalumab is an extraordinary drug that has meaningfully
improved the quality of life of some of my most difficult-to-treat
psoriasis patients, many of whom achieved complete skin clearance
with this treatment," said Dr. Mark
Lebwohl, Chairman, Department of Dermatology, Mount Sinai
School of Medicine. "I am very pleased that the Advisory Committee
has recommended that this life-changing treatment should be
available to psoriasis patients who require a treatment with
brodalumab's unique mechanism of action, and I look forward to
prescribing this therapy to patients who are suffering from the
devastating effects of moderate to severe plaque
psoriasis."
As previously announced, the Marketing Authorisation Application
(MAA) for brodalumab in psoriasis was accepted by the European
Medicines Agency (EMA) in Q42015. In August
2015, Valeant entered into a collaboration agreement with
AstraZeneca (AZN.LN, NYSE:AZN ) granting Valeant an exclusive
license to develop and commercialize brodalumab globally, except in
Japan and certain other Asian
countries where rights are held by Kyowa Hakko Kirin Co.,
Ltd. In July 2016, AstraZeneca
and Valeant amended Valeant's license for brodalumab to terminate
Valeant's right to develop and commercialize brodalumab in
Europe. LEO Pharma currently holds exclusive rights to
develop and commercialize brodalumab in Europe, and Valeant holds the license to
develop and commercialize brodalumab in the U.S and other
territories, other than Japan and
certain other Asian countries. In July
2016, brodalumab was granted approval from the Ministry of
Health, Labour and Welfare Japan.
About brodalumab
Brodalumab is a novel human
monoclonal antibody that binds to the interleukin-17 (IL-17)
receptor and inhibits inflammatory signaling by blocking the
binding of several types of IL-17 to the receptor. By stopping
IL-17 from activating the receptor, brodalumab prevents the body
from receiving signals that may lead to inflammation. The IL-17
pathway plays a central role in inducing and promoting inflammatory
disease processes.
Safety Information
The most common adverse reactions
were headache, arthralgia, fatigue, oropharyngeal pain, and
diarrhea. Caution should be exercised when prescribing to patients
with a history of Crohn's disease. Suicidal ideation and
behavior have been reported. The potential risks and benefits
should be weighed before using brodalumab in patients with a
history of depression and/or suicidal ideation or behavior. Serious
infections have occurred therefore caution should be exercised when
considering the use of brodalumab in patients with a chronic
infection or a history of recurrent infection. Patients should be
evaluated for tuberculosis infection prior to initiating
treatment.
About Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical
company that develops, manufactures and markets a broad range of
pharmaceutical products primarily in the areas of dermatology,
gastrointestinal disorders, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements respecting the potential of brodalumab and its review
and approval by the FDA. Forward-looking statements may
generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. Readers are cautioned not to place undue reliance on
any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this press release or to reflect actual outcomes,
unless required by law.
Contact Information:
Laurie W. Little
laurie.little@valeant.com
or
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
Logo -
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-approval-of-brodalumab-for-treatment-of-moderate-to-severe-plaque-psoriasis-300300963.html
SOURCE Valeant Pharmaceuticals International, Inc.