LAVAL, Quebec, Jan. 25, 2016 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA)
submitted by AstraZeneca in partnership with Valeant, for
brodalumab injection, 210 mg, a monoclonal antibody that targets
the IL-17 receptor, in development for patients with
moderate-to-severe plaque psoriasis. The FDA has assigned a
Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
The Marketing Authorisation Application (MAA) for brodalumab in
psoriasis was accepted by the European Medicines Agency (EMA) in
Q42015. In October, 2015, Valeant entered into a collaboration
agreement with AstraZeneca under which Valeant has an exclusive
license to develop and commercialise brodalumab globally, except in
Japan and certain other Asian
countries where rights are held by Kyowa Hakko Kirin Co., Ltd.
The brodalumab BLA is supported by data from the three AMAGINE
Phase III pivotal studies. The results highlighted that brodalumab
has an effective mechanism of action that could help a significant
number of moderate-to-severe plaque psoriasis patients achieve
total clearance of their skin disease. At the 210 mg dose,
brodalumab was shown to be effective in total skin clearance of
psoriasis compared to placebo and superior to ustekinumab, a
leading approved psoriasis treatment, at week 12 in two replicate
comparator trials involving over 3,500 patients.
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 AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com
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 disorder,
eye health, neurology and branded generics. More information about
Valeant can be found at www.valeant.com.
Contact Information:
Laurie W.
Little
949-461-6002
laurie.little@valeant.com
Elif McDonald
905-695-7607
elif.mcdonald@valeant.com
Media:
Renée E. Soto/Meghan Gavigan
Sard Verbinnen & Co.
212-687-8080
rsoto@sardverb.com / mgavigan@sardverb.com
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SOURCE Valeant Pharmaceuticals International, Inc.