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news.Janssen-Cilag International (Janssen) has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of Stelara (ustekinumab) to treat moderate to severe plaque psoriasis in adolescent patients.
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The company is seeking approval for adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
The positive opinion was based on data from the Cadmus study, a randomized, double-blind, placebo-controlled, parallel, multicentre Phase III trial designed to evaluate the safety and efficacy of Stelara in patients aged 12 to 17 years with moderate to severe plaque psoriasis.
In Cadmus study, a total of 100 patients had a diagnosis of plaque-type psoriasis for at least six months prior to first study agent administration and had a moderate to severe disease defined by a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician’s Global Assessment (PGA) score greater than or equal to three and body surface area (BSA) involvement of at least 10%.
Janssen Research & Development vice-president, Immunology Development head Newman Yeilding said: "Today’s recommendation of Stelara for the treatment of paediatric psoriasis is an important step forward for adolescents living with this chronic, debilitating autoimmune disease."
The European Commission (EC) will review the CHMP’s positive opinion and issue a final decision during the third quarter of 2015.
Plaque psoriasis is a chronic autoimmune disease, and affects from 0.5 to 2% of the general population during childhood and adolescence.
If approved, Stelara will become available for the treatment of adolescents from the age of 12 years and older living with this disease.