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news.Valeant Pharmaceuticals International has received notification from the US Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant's New Drug Application (NDA) for brodalumab on July 19, 2016.
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On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) 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 assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
"Plaque psoriasis is a chronic disease of the immune system that can impair many aspects of patients’ lives," said Joseph C. Papa, chairman and chief executive officer.
"We look forward to the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about this novel antibody we are developing."
As previously announced, 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.
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.