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:5/24/2017)... As Ebola resurfaces in the Democratic ... suspected cases now reported, a new analysis of the Ebola ... correlation between the 2014 and 2017 outbreaks of the disease.  ... 2012-13, which preceded the 2014 outbreak. An analysis of the ... counts in 2014-15, which again precedes the current outbreak in ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... month its 20th anniversary, marking the occasion with a strong presence at Bio-IT ... Welcome Reception and further extends an invitation to all attendees to view ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... technology applications, has announced a facility expansion to accommodate its rapid growth. , ... of new workspace and renovation of the existing areas. The expansion includes, a ...
(Date:5/23/2017)... Switzerland (PRWEB) , ... May 23, 2017 , ... ... forces machine manufacturers to re-engineer their control technology again and again. METTLER TOLEDO ... problem for machine manufacturers. The videos illustrate how integration of the ACT350 into ...
Breaking Biology Technology:
(Date:3/24/2017)... Controller General of Immigration from Maldives Mr. Mohamed Anwar and ... international IAIR Award for the most innovative high security ePassport and eGates  ... ... Maldives Immigration Controller General, Mr. Mohamed Anwar ... right) have received the IAIR award for the "Most innovative high security ...
(Date:3/22/2017)... VILNIUS, Lithuania , March 21, 2017 /PRNewswire/ ... identification and object recognition technologies, today announced the ... development kit (SDK), which provides improved facial recognition ... safety cameras on a single computer. The new ... algorithms to improve accuracy, and it utilizes a ...
(Date:3/20/2017)... PMD Healthcare announces the release of its ... System (WMS), a remote, real-time lung health monitoring and ... is a Medical Device, Digital Health, and Chronic Care ... innovative solutions that empower people to improve their healthcare ... developed the first ever personal spirometer, Spiro PD, which ...
Breaking Biology News(10 mins):