Johnson & Johnson's pharmaceutical arm Janssen Pharmaceuticals Inc. has applied to the U.S. Food and Drug Administration for a wider indication of its psoriasis drug Stelara to treat children.
Stelara was previously approved in the U.S. for plaque psoriasis and Crohn's disease patients over the age of 12. The new application, if approved by the regulator, would allow prescriptions for children as young as 6 years old.
Otherwise known as ustekinumab, Stelara is the only anti-inflammatory drug that targets proteins in the blood called interleukin 12 and interleukin 23 to treat auto-immune conditions like psoriasis.
The application relies on results from a late-stage study called Cadmus Jr. that showed 77% of patients saw cleared or minimal signs of psoriasis over 12 weeks. The study continued for 56 weeks to evaluate safety.
"Children with psoriasis struggle to manage its symptoms, while their families struggle to find an efficacious and safe treatment option," said Newman Yeilding, head of immunology development at Janssen Research & Development, in an Oct. 7 press release. "We're eager to bring this therapy, with a well-established safety and efficacy profile in plaque psoriasis and other immune diseases, one step closer to being available to children living with this chronic disease."
Janssen also applied for the pediatric indication in Europe, where Stelara is approved for adults and adolescents with plaque psoriasis, Crohn's disease and ulcerative colitis.
An estimated 125 million people around the world have psoriasis, and about one-third of patients in the U.S. show signs of the disease before the age of 20.
