Skip to NavigationSkip to content

European Commission expands Stelara for paediatric moderate to severe plaque psoriasis

Published on 24/01/20 at 11:48am

Janssen’s Stelara (ustekinumab) has seen its label expanded in Europe to include the treatment of moderate to severe plaque psoriasis in children aged from 6 to 11, it has emerged.

The approval followed a previous positive opinion from the EMA’s Committee for Medicinal Products for Human Use marks the availability in Europe of the first biologic within this patient group to target the IL-23/IL-12 pathway

Phase 3 data submitted in support of the decision showed that the therapy met its primary endpoint of the proportion of patients who achieved a physician’s global assessment (PGA) score of either cleared (0) or minimal (1) after 12 weeks of treatment. The drug also showed benefit in improving quality of life as well as the signs and symptoms of plaque psoriasis.

“This latest EC approval is a significant milestone for young children struggling to cope with the symptoms of psoriasis,” said Lloyd Miller, Vice President, Immunodermatology Disease Area Leader at Janssen. “We’re delighted that this therapy, which has a well-established safety and efficacy profile in adults with plaque psoriasis and other immune diseases, is now expanded to children as young as six who are living with this chronic disease.”

Around a third of the 14 million incidence of psoriasis in Europe affect children, and the condition can impact mental health and quality of life in the long term.

Matt Fellows

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches