The European Commission (EC) has announced an expansion for the indication of Janssen’s Stelara (ustekinumab), which will now be available for the treatment of paediatric patients (ages 6–11) with moderate to severe plaque psoriasis.
Previously, the drug was approved for use in adolescent and adult patients with plaque psoriasis aged 12 years and older, but on the news will become the first available biologic treatment in this patient population to selectively address the IL‑23/IL‑12 pathway.
The company Johnson & Johnson owned company says that the new approval is based on results from the Phase III CADMUS Jr study, building on the prior Phase III CADMUS study, which found that the therapy improved the signs and symptoms of plaque psoriasis, as well as health‑related quality of life in the younger patients.
The 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, Janssen Research & Development, “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.”
The news is a welcome boost for Janssen, as last week the National Institute for Health and Care Excellence (NICE) released a draft guidance not recommending the medicine for moderately to severely active ulcerative colitis in adults.
Despite there being an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies or they stop working, the organisation said there is considerable uncertainty about the cost-effectiveness estimates for the Stelara.
However, Janssen has responded by stating that it is “committed to continue collaborating closely with NICE throughout the subsequent stages of the appraisal.”
Psoriasis is an immune-mediated inflammatory disease that affects the skin, resulting in areas of red or inflamed skin covered with silvery scales, which are known as plaques. The condition can have a profound, long-term impact on the psychological health and overall quality of life for children.
