U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

STELARA is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for pediatric psoriasis use, providing a new proven treatment for children (6-11 years of age) who have had few available options

HORSHAM, PA, USA I July 30, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO). Plaque psoriasis is the most common form of psoriasis in adults and children.1 STELARA targets both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including PsO. STELARA is administered as an injection given under the skin, dosed four times per year after two starter doses.

"We are thrilled that the latest approval for STELARA will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases," said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. "While STELARA is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options."

The FDA approval of STELARA for pediatric use is based on results from the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical trial, of 44 patients with moderate to severe plaque psoriasis in which 77 percent of patients achieved clear or almost clear skin, at week 12 after two doses. Secondary endpoints included the proportion of patients achieving 75 percent or 90 percent improvement in their Psoriasis Area and Severity Index (PASI) score at week 12 compared to baseline. Study results showed 84 percent and 64 percent of patients achieved a PASI 75 response and PASI 90 response, respectively. In general, the safety profile observed in CADMUS Junior was similar to the safety profile from studies in adults with plaque psoriasis.1 Patients knew they were on STELARA for the entirety of the study, which may affect results.

Click to Tweet: #BREAKING: The @US_FDA approves expanded indication for STELARA® (ustekinumab). Read more: https://bit.ly/395z0bK

"Plaque psoriasis presents differently in all patients, making it a challenging disease to both diagnose and treat. Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment," said Stacie Bell, Ph.D., Chief Scientific and Medical Officer, National Psoriasis Foundation. "The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis."

Access for STELARA
Janssen will work closely with payers, providers and pharmacy benefit managers in an effort to help ensure STELARA is broadly accessible and affordable for patients living with PsO.

Janssen CarePath offers a comprehensive support program that helps patients get started on STELARA and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

About Psoriasis
Plaque psoriasis (PsO) is the most common form of psoriasis in adults and children. It is an inflammatory, immune-mediated disease resulting in overproduction of skin cells which causes raised, red, scaly plaques that may be itchy or painful.2 It is estimated that more than 8 million Americans and about 125 million people worldwide live with the disease. Nearly one-quarter of all people with PsO have cases that are considered moderate to severe.3 About one-third of people with psoriasis first have symptoms before the age of 20 years and approximately 20,000 children under the age of 10 are diagnosed with psoriasis.2

About STELARA® (ustekinumab)
STELARA® (ustekinumab), is the first and only biologic treatment in this patient population to target the interleukin (IL) 12/IL-23 pathways, an important therapeutic target for the condition.4 With this approval, STELARA is now the only IL-12/IL-23 inhibitor approved in the United States for the treatment of: 1) adults and pediatric patients 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

1 Philipp S, Menter A, Nikkels A. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (≥6 to <12 years of age): efficacy, safety, pharmacokinetic, and biomarker results from the open-label CADMUS Jr study. [published online ahead of print March 16, 2020]. Br J Dermatol. doi: 10.1111/Bjd.19018.
2 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed June 2020.
3 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed June 2020.
4 Benson J, et al. Discovery and mechanism of ustekinumab. MAbs 2011;3:535–45.

SOURCE: Janssen

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