Janssen Submits Application Seeking Approval Of STELARA In European Union For Pediatric Plaque Psoriasis

BEERSE, Belgium, Oct. 10, 2014 /PRNewswire/ --Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.1

"Janssen is committed to the continued development of STELARA, especially in this underserved pediatric population," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from STELARA."

The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving STELARA compared with patients receiving placebo.

About CADMUS CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients ages 12 to 17 years with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed more than six months prior to first study agent administration with a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.

Patients were randomized 1:1:1 to receive subcutaneous placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].

About Psoriasis Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide, including 14 millionEuropeans.2-6 Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling.7 It is estimated that nearly 3 percent of the world's population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.2 Although the disease can present at any age, approximately one-third of people who develop psoriasis are under the age of 20 when the disease first surfaces.8 Prevalence in childhood and adolescence varies by region, ranging from 0.5 to 2 percent of the general population.1

About STELARA (ustekinumab)STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved in 79 countries for the treatment of moderate to severe plaque psoriasis. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in immune-mediated inflammatory diseases, including psoriasis and psoriatic arthritis.

In the European Union, STELARA is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen plus UVA). STELARA is also approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Janssen Biotech, Inc. discovered and developed STELARA, and the Janssen Pharmaceutical Companies maintain exclusive worldwide marketing rights to STELARA.

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Janssen Submits Application Seeking Approval Of STELARA In European Union For Pediatric Plaque Psoriasis