FDA Approves STELARA for Adolescents with Moderate to Severe Plaque Psoriasis

Janssen Biotech announced the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today's approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents.

"Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents," said Andrew Greenspan, M.D., Vice President of Medical Affairs at Janssen. "With today's approval, STELARA has the potential to make a meaningful difference in the lives of these young adults."

The approval of STELARA for the adolescent indication in moderate to severe plaque psoriasis is based on data from a Phase 3 study designed to evaluate the efficacy and safety of subcutaneous administration of STELARA in patients aged 12 years or older. At least two-thirds of patients receiving STELARA were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician's Global Assessment score of 0 or 1 (cleared or minimal psoriasis). Safety findings for adolescent patients treated with STELARA were consistent with those seen in studies in adults with plaque psoriasis.

Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells. It is estimated that more than 7.5 million Americans live with the disease. The most common form of psoriasis, affecting about 80 to 90 percent of psoriasis patients, is plaque psoriasis characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. Approximately 80 percent of those affected with psoriasis have mild to moderate disease, while 20 percent have moderate to severe plaque psoriasis. The scalp and face are the most affected areas in adolescents. This can lead to emotional and social complications in this population.

STELARA, a fully human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine used to treat adults and children 12 years of age and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). STELARA is administered subcutaneously at weeks 0 and 4, and then every 12 weeks thereafter.

STELARA is also indicated for the treatment of adult patients 18 years and older with active psoriatic arthritis, alone or with the medicine methotrexate, and for the treatment of adult patients 18 years or older with moderately to severely active Crohn's disease who have already taken other medicines that did not work well enough or they could not tolerate it.