European Commission expands Stelara for paediatric moderate to severe plaque psoriasis

pharmafile | January 24, 2020 | News story | Research and Development |  Europe, Janssen, Stelara, pharma 

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