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New Biologic STELARA(TM) Receives Approval in Europe for Treatment of Moderate to Severe Plaque Psoriasis
Date:1/22/2009

First and Only Biologic Approved with Infrequent, Every Twelve-Week Maintenance Dosing

BEERSE, Belgium, Jan. 22 /PRNewswire/ -- Janssen-Cilag announced today that STELARA(TM) (ustekinumab), the first in a new class of biologics, has been approved by the European Commission for use across Europe. The approved indication of 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 PUVA (psoralen plus ultraviolet A light). With the approval by the European Commission, ustekinumab is approved in 27 countries in the EU. Psoriasis, a chronic skin disease that affects between two and three percent of the European population,(1) is associated with substantial physical and emotional burdens and potentially serious co-morbidities.(2,3)

In clinical studies, treatment with ustekinumab demonstrated significant improvements in patients' psoriasis, and quality of life, which were sustained with as few as four injections a year (every twelve weeks) following two starter doses at weeks 0 and 4. The approval of ustekinumab offers adults living with moderate-to-severe plaque psoriasis a new therapy which has the potential to make a considerable impact on their daily lives.

The approval is based on data from two large, pivotal Phase III, multi-centre, randomised, 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.(4,5) Two-thirds or more of patients achieved the primary endpoint of each trial, at least 75% improvement in psoriasis using the Psoriasis Area and Severity Index (PASI 75) at week 12, after receiving just two doses of ustekinumab 45 mg or 90 mg, respectively, at weeks
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SOURCE Janssen-Cilag
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