Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Horsham, Pa., October 13, 2017 ― Janssen Biotech, Inc., announced today that 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. 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.”
What is 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.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. This can lead to emotional and social complications in this population.
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. Follow us on Twitter at https://twitter.com/JanssenUS or https://twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding benefits of an expanded indication for STELARA® (ustekinumab). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success for new indications; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
 National Center for Biotechnology Information. Management of Psoriasis in Adolescence. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961070/. Accessed October 10, 2017
 National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed October 10, 2017.
 American Academy of Dermatology. Psoriasis. https://www.aad.org/media/stats/conditions/psoriasis. Accessed October 10, 2017.
 National Center for Biotechnology Information. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744260/#CR7. Accessed October 10, 2017.
Source: Janssen Biotech, Inc.
Posted: October 2017
- FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis - July 30, 2020
- Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis - October 21, 2019
- FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease - September 26, 2016
- Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis - September 23, 2013
- FDA Approves Stelara (ustekinumab) to Treat Psoriasis - September 25, 2009
- FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months - May 27, 2009
- FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application - December 19, 2008
- FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months - August 8, 2008
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis - December 7, 2007
- Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis - December 4, 2007
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