Navigation Links
FDA Extends Review Timeline for STELARA(TM) (ustekinumab) Biologic License Application by Three Months
Date:5/26/2009

HORSHAM, Pa., May 26 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

The amendment, submitted within three months of the user fee goal date, pertains to testing results to establish the product's shelf life. The FDA has requested no additional clinical trials for STELARA. The U.S. BLA extension does not affect the approval or marketing of STELARA in Europe or Canada, nor does it apply to pending applications in other markets.

"We remain focused on collaborating with the FDA and providing the necessary information to support the review and approval of STELARA for the treatment of adults with moderate to severe plaque psoriasis," said Jay P. Siegel, M.D., Chief Biotechnology Officer.

The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended STELARA for approval in June 2008. In December 2008, Centocor Ortho Biotech announced the receipt of a Complete Response letter for STELARA from the FDA requesting additional information, including a proposal for a Risk Evaluation and Mitigation Strategy (REMS), to which Centocor Ortho Biotech responded in January 2009. The FDA's review of the proposed REMS for STELARA and the proposed product labeling is ongoing.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that 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 Americans and nearly 3 percent of the world's population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About STELARA

STELARA 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.

STELARA is approved in Canada for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. In Europe, 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 and PUVA (psoralen plus ultraviolet A light).

Centocor discovered STELARA 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 Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com. Centocor Ortho Biotech is a wholly-owned subsidiary of Johnson & Johnson.

(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 Ortho Biotech Inc. and/or Johnson & Johnson'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 28, 2008. 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. Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)


'/>"/>
SOURCE Centocor Ortho Biotech Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. GSK Extends Strategic Collaboration with Aspen
2. BD Extends Decade-Long Support for UNICEFs Campaign to Eliminate Maternal and Neonatal Tetanus
3. IH Systems Extends Global Reach into South Korean Medical Device Market
4. Frontier Airlines Extends Mexico Travel Policy for Customers With Concerns About Swine Flu
5. U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months
6. Sun Pharmaceutical Extends Tender Offer for Taro
7. Home-Based Program Extends Seniors Lives
8. CVS Caremark Extends Google Health Partnership Enabling CVS/pharmacy Customers to Add Prescription Information to Personal Health Records
9. Childrens Hospital of Wisconsin Extends Real-Time Asset Tracking and Automated Charge Capture to their New Patient Pavilion
10. FEMA Extends Formaldehyde Testing Contract with Bureau Veritas
11. tw telecom Extends Portland Area Network Into Tualatin and Lake Oswego Business Districts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Consumers have ... and regulators/payers have placed more emphasis on patient ... patient support programs in the pharmaceutical industry have ... medications. Consequently, pharmaceutical companies are focusing on becoming ... are providing products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
Breaking Medicine Technology: