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news.Janssen-Cilag, a research-based pharmaceutical company, has received approval from the European Commission for Stelara, the first in a new class of biologics, for use across Europe. With the approval from the European Commission, ustekinumab is approved in 27 countries in the EU.
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The approval is based on data from two large, pivotal Phase III, multi-center, randomized, double-blind, placebo controlled trials, Phoenix 1 & 2, involving nearly 2,000 patients in whom the efficacy and safety of ustekinumab in the treatment of moderate-to-severe plaque psoriasis were evaluated.
The approved indication of Stelara (ustekinumab) is for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen plus ultraviolet A light.