FDA approves Janssen’s Stelara for the Treatment of Adolescents with Moderate-to-Sever Plaque Psoriasis

Janssen Biotech, Inc., announced that the U.S. 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.[1] Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, STELARA® has become a leading therapeutic option for dermatologists and their patients, with only four doses a year after two starter doses.

“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 (PGA) 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 highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques,” said Michael Siegel, Ph.D., Senior Vice President of Research and Clinical Affairs for the National Psoriasis Foundation. “It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives.”[2]

What is Psoriasis?
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells.[3] It is estimated that more than 7.5 million Americans live with the disease.[4] 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.3 Approximately 80 percent of those affected with psoriasis have mild to moderate disease, while 20 percent have moderate to severe plaque psoriasis.4 The scalp and face are the most affected areas in adolescents.[5] This can lead to emotional and social complications in this population.5

What is STELARA® (ustekinumab)?
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.

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com

Media Contact
Megan Farina
Office: +1 610-724-0179
mfarina@its.jnj.com

Brian Kenney
Office: +1 215-628-7010
Mobile: +1 215-620-0111
bkenney1@its.jnj.com

Investor Contact
Joseph J. Wolk
Johnson & Johnson
Office: +1 732-524-1142

Lesley Fishman
Johnson & Johnson
Office: +1 732-524-3922