FDA OKs AstraZeneca’s Psoriasis Drug


From DCAT Value Chain Insights (VCI)

By Pharma News posted 02-21-2017 11:09

  

AstraZeneca and its partner, Valeant Pharmaceuticals, have received US Food and Drug Administration approval for Siliq (brodalumab) injection, a drug for treating moderate-to-severe plaque psoriasis, an inflammatory disease. The specific indication is for treating adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies for moderate-to-severe plaque psoriasis.

Through a collaboration agreement, AstraZeneca granted Valeant the exclusive license to develop and commercialize Siliq globally, except in Japan, certain other Asian countries, and Europe. In Japan and certain other Asian countries, rights to Siliq are held by Kyowa Hakko Kirin through an agreement with Amgen. In Europe, LEO Pharma, a Ballerup, Denmark-headquartered pharmaceutical company specializing in dermatology and critical care, holds exclusive rights to develop and commercialize brodalumab, the active ingredient in Siliq, through an agreement entered in July 2016.

Under the agreement, AstraZeneca will receive a milestone payment of $130 million from Valeant at first regulatory approval. Following the approval, AstraZeneca and Valeant will share profits from the sale of Siliq in the US market.

Siliq is a human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. The IL-17 pathway plays a role in inducing and promoting inflammatory disease processes, according to AstraZeneca.

Source: AstraZeneca 

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