FDA Complete Response Letter Ustekinumab BLA
FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application
HORSHAM, Pa., December 19, 2008 /PRNewswire/ -- Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque psoriasis.
The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). FDA requires REMS to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS must contain a Medication Guide and communication plan. It does not require restricted distribution. The FDA has not requested any new non-clinical or clinical studies evaluating the efficacy or safety of ustekinumab prior to approval.
"We are confident that we can expeditiously address the questions set forth in the Complete Response letter," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "We anticipate responding to the FDA in January 2009 and remain focused on bringing ustekinumab to market and ultimately to appropriate patients living with psoriasis and in need of treatment."
On June 17, 2008, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended ustekinumab for approval. DODAC is convened on request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of dermatologic and ophthalmologic conditions. The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug.
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 approximately 7.5 million people in the United States and 10 million Europeans are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.
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 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 the body's regulation of immune responses and that are also believed to play a role in inflammatory disorders, including psoriasis.
On November 21, 2008, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to other systemic therapies.
On December 12, 2008, the Canadian Health Authority approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.
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. Centocor and Janssen-Cilag are subsidiaries of Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Centocor does not undertake to update any forward-looking statements as a result of new information or future events or developments.
CONTACT: Media: Brian Kenney of Centocor, Inc., +1-215-325-2107, Mobile:+1-215-620-0111; or Investors: Louise Mehrotra, +1-732-524-6491, or TinaPinto, +1-732-524-2034, both of Johnson & Johnson
Web site: http://www.jnj.com/
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: December 2008
- Stelara (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis - August 1, 2022
- 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 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
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 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
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.