StelaraTreatment for Psoriasis, Psoriatic Arthritis, Crohn's Disease -- Maintenance, Ulcerative Colitis
Update: Stelara (ustekinumab) Now FDA Approved - September 25, 2009
Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
HORSHAM, Pa., February 4, 2008 /PRNewswire/ -- Centocor, Inc. announced today that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis.
"We are pleased by the FDA's acceptance of our Biologics License Application for review of ustekinumab," stated Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "Ustekinumab has yielded promising efficacy and safety results in Phase 3 clinical trials, and we look forward to working closely with the FDA during their ongoing review of this potential new treatment for psoriasis."
Centocor, Inc. announced that it had submitted the BLA for ustekinumab in December 2007 based on its comprehensive development program including data from two large Phase 3 multicenter, randomized, double-blind, placebo- controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque-type psoriasis. The primary endpoint of both studies was the proportion of patients who achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75). Acceptance of the BLA filing does not mean that a license has been issued for this product nor does it represent any evaluation of the adequacy of the data submitted in the BLA. In December 2007 the Marketing Authorization Application (MAA) for ustekinumab was submitted in Europe and is currently under review by the European Medicines Agency (EMEA).
One-year findings from one of two ustekinumab Phase 3 trials were presented for the first time at the annual meeting of the American Academy of Dermatology this past Saturday, February 2.
Psoriasis is a chronic, immune-mediated disease, which results from the overproduction of skin cells resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that 125 million people worldwide have psoriasis, including two percent of both the U.S. and European populations, or some 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.(1)
Ustekinumab is a new, human monoclonal antibody in Phase 3 development by Centocor, Inc. for the treatment of moderate to severe plaque psoriasis, and is being investigated as an infrequently administered subcutaneous injection. Ustekinumab is a novel biologic therapy that targets interleukin 12 (IL-12) and interleukin 23 (IL-23), naturally occurring proteins that are important in regulating the immune system and that are also believed to play a role in immune-mediated inflammatory disorders.
Centocor discovered ustekinumab and has exclusive marketing rights to the product in the United States. Janssen-Cilag companies have exclusive marketing rights in all countries outside of the United States.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.
1. National Psoriasis Foundation.
CONTACT: Media contacts, Brian Kenney, Centocor, Inc., +1-215-325-2107,+1-215-620-0111 Mobile; Investor contacts, Louise Mehrotra,+1-732-524-6491, or Tina Pinto, +1-732-524-2034, both of Johnson & Johnson
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Posted: February 2008
- 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
- Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis - October 13, 2017
- 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
- 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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