Janssen Submits Application to U.S. FDA Seeking Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

SPRING HOUSE, PA, USA I October 7, 2019 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO).

STELARA is the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, which evidence suggests play an important role in inflammation associated with auto-immune conditions, such as PsO, and is the only drug that blocks these cytokines that is approved for adolescent use. STELARA is currently approved in many countries for the treatment of adolescents and adults with moderate to severe plaque psoriasis (ages 12+), adults with active psoriatic arthritis, adults with moderate to severe Crohn's disease and adults with moderate to severe ulcerative colitis in the EU.

The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study, in which the primary endpoint of the proportion of patients achieving a Physician's Global Assessment (PGA) score of Cleared (0) or Minimal (1) at week 12 was met. At week 12, 77 percent of patients (confidence interval [CI]: 62 percent, 89 percent) achieved PGA 0/1 response. The safety profile observed for STELARA in CADMUS Jr was generally consistent with previous studies as well as the current prescribing information for STELARA. The results of the study were presented earlier this year at the Skin Inflammation & Psoriasis International Network (SPIN) Annual Congress.

"Children with psoriasis struggle to manage its symptoms, while their families struggle to find an efficacious and safe treatment option," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "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."

In addition to the primary endpoint, multiple secondary endpoints were assessed in the CADMUS Jr study. These include the proportions of patients achieving 75 percent or 90 percent improvement in their Psoriasis Area and Severity Index score at week 12 compared to baseline, and the change in Children's Dermatology Life Quality Index score at week 12 compared to baseline. Safety was evaluated through week 56.

CADMUS Jr was an open-label, single-arm, multicenter Phase 3 study designed to evaluate the efficacy and safety of STELARA administered by subcutaneous injection in pediatric patients with moderate to severe PsO. The study evaluated 44 participants and continued through 56 weeks.

Janssen also submitted a marketing application this year to the European Medicines Agency seeking approval of STELARA as a treatment for pediatric PsO patients.

About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions or plaques, which can cause physical pain and itching.1 It is estimated that 125 million people worldwide live with the disease.2 Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.2 In the United States, about one-third of people with psoriasis experience symptoms before the age of 20 years.3

About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 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 who have failed or were intolerant to immunomodulators or corticosteroids, or failed or were intolerant to anti-TNF therapies.

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. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

  1. American Academy of Dermatology. What is Psoriasis? https://www.aad.org/public/diseases/scaly-skin/psoriasis/what-is-psoriasis. Accessed September 23, 2019
  2. National Psoriasis Foundation. https://www.psoriasis.org/content/statistics. Accessed September 23, 2019.
  3. Medical News Today. What to know about psoriasis in children. https://www.medicalnewstoday.com/articles/319656.php. Accessed September 23, 2019

SOURCE: Janssen

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