J&J's Janssen Submits Applications Requesting Approval of STELARA in US, Europe

J&J's JNJ Janssen Biotech, Inc. and Janssen Biologics B.V. announced today the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) requesting approval of STELARA® (ustekinumab) for the treatment of adult patients with active psoriatic arthritis. It is estimated that more than two million people in the U.S.[1] and approximately 4.2 million people across Europe[2],[3],[4] are living with psoriatic arthritis, a chronic autoimmune disease characterized by both joint inflammation and psoriasis skin lesions, for which there is no cure. "We are pleased to present applications to health authorities in the U.S. and Europe seeking approval of STELARA for the treatment of active psoriatic arthritis, a chronic, debilitating immune-mediated inflammatory disease," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. "The efficacy and safety of STELARA, an anti–interleukin-12/23 antibody, have been evaluated in a large Phase 3 clinical development program for the treatment of active psoriatic arthritis, a disease for which tumor necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed." The applications are supported by findings from P hase 3 Multicenter, Randomi s ed, Double-blind, Placebo-controlled trials of U stekinumab, a Fully Human anti–IL-12/23p40 M onoclonal Antibody, Ad m inistered Subcutaneously, i n Subjects with Active Psoriatic Ar t hritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously administered STELARA 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks. The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL in spite of previous treatment with conventional therapy. PSUMMIT II also included patients with previous exposure to tumor necrosis factor (TNF) inhibitors. The primary endpoints for both studies were the proportion of patients demonstrating at least a 20 percent improvement in arthritis signs and symptoms [American College of Rheumatology (ACR) 20] at week 24. Secondary endpoints at week 24 included in the submissions were: improvements in Health Assessment Questionnaire Disability Index (HAQ-DI) scores, a 50 or 70 percent improvement in arthritis signs and symptoms (ACR 50 or ACR 70), and at least a 75 percent improvement in psoriatic skin lesions as measured by the Psoriasis Area Severity Index (PASI 75) in patients with at least three percent body surface area involvement at baseline. Data from the Janssen Research & Development–sponsored PSUMMIT I and PSUMMIT II studies were recently presented at the 2012 Annual Meeting of the American College of Rheumatology.