Navigation Links
FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Date:8/8/2008

HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The FDA extended the review period to provide additional time for review of amendments to the application provided by Centocor within the last three months. The FDA has requested no additional clinical trials.

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. Ustekinumab is also under review by the European Medicines Agency (EMEA).

About Psoriasis

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.

About Ustekinumab

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 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.


'/>"/>
SOURCE Centocor, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Roche Extends Tender Offer for Ventana
2. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
3. NASA Extends Cooperative Agreement With NSBRI
4. Organon Extends MetaCore License and Adds MetaLink
5. NPS Pharmaceuticals, Inc. Announces an Increase in Tender Offer Price for Its 3.0% Convertible Notes Due 2008 and Extends Expiration Date Until October 17, 2007
6. Roche Extends Tender Offer for Ventana
7. GSK Extends GeneGo License and Adds New Products
8. Netsmart Technologies Extends Relationship with Manatee Glens for Enterprise Behavioral Health Software Solutions
9. Evotec Extends Ongoing Collaboration With CHDI Worth up to US$ 37 Million
10. Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product
11. Ingenuity Systems Extends Enterprise-Level Software Agreement With GlaxoSmithKline
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2017)... 2017  Kibow Biotech Inc., a pioneer in developing ... of a new patent covering a unique method for ... Patent and Trademark Office on May 23 rd ... of Bio award in 2014 in San ... approaches to chronic disease. Renadyl™, the first and only ...
(Date:6/19/2017)... ... 2017 , ... As Vice President, Product Services, Mr. Guinter ... support, and client process and SOP development. , Mr. Guinter brings a wealth ... for service providers and top-tier pharmaceuticals, and as an independent consultant supported a ...
(Date:6/16/2017)... ... June 16, 2017 , ... ... has just announced two more sessions of its “From the Helm” Webinar Series. ... the world of online templates for design control exercises. Led by David Cronin, ...
(Date:6/15/2017)... CT (PRWEB) , ... June 15, 2017 , ... ... that it has secured a Series B round of financing in the amount ... a group of private investors participated in the round. , The Series B ...
Breaking Biology Technology:
(Date:6/14/2017)... -- IBM (NYSE: IBM ) is introducing several innovative partner ... developing collaboration between startups and global businesses, taking place in ... event, nine startups will showcase the solutions they have built ... France is one of ... 30 percent increase in the number of startups created between ...
(Date:5/6/2017)... RAM Group , Singaporean based ... in biometric authentication based on a novel  ... to perform biometric authentication. These new sensors are based on ... Ram Group and its partners. This sensor will have ... and security. Ram Group is a next generation ...
(Date:4/17/2017)... , April 17, 2017 NXT-ID, Inc. (NASDAQ: ... announces the filing of its 2016 Annual Report on Form 10-K ... Commission. ... 10-K is available in the Investor Relations section of the Company,s ... the SEC,s website at http://www.sec.gov . 2016 Year ...
Breaking Biology News(10 mins):