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:4/29/2016)... ... April 29, 2016 , ... Summit for Stem Cell has ... development of a patient-specific stem cell therapy for the treatment of Parkinson’s disease. The ... Jeanne Loring at The Scripps Research Institute in San Diego, CA. , ...
(Date:4/28/2016)... Q BioMed Inc. (OTCQB:QBIO), ...  was featured in an article he wrote on ... To Tread: http://www.lifescienceleader.com/doc/accelerators-enter-when-vcs-fear-to-tread-0001 ... an essential business journal for life science executives ... Big Pharmas. Their content is designed to inform ...
(Date:4/28/2016)... Connecticut (PRWEB) , ... April 28, 2016 , ... ... Group, Inc., will hold an open house for regional manufacturers at its Maple ... displays from Tsugami, Okuma, Hardinge Group, Chiron and Trumpf. Almost 20 leading ...
(Date:4/27/2016)... NY (PRWEB) , ... April 27, 2016 , ... ... it. Touch screen mobile devices with fingerprint recognition for secure access, voice ... are only a few ways consumers are interacting with biometrics technology today. ...
Breaking Biology Technology:
(Date:3/11/2016)... Germany , March 11, 2016 http://www.apimages.com ... - Cross reference: Picture is available at AP Images ( http://www.apimages.com ... from DERMALOG will be used to produce the new refugee identity ... other biometric innovations, at CeBIT in Hanover ... scanner from DERMALOG will be used to produce the new refugee ...
(Date:3/9/2016)... NEW YORK , March 9, 2016 ... current and future states of the RNA Sequencing (RNA ... in segments such as instruments, tools and reagents, data ... Analyze various segments of the RNA-Sequencing market such ... RNA-Sequencing services Identify the main factors affecting each segment ...
(Date:3/3/2016)... , March 3, 2016  FlexTech, a SEMI ... categories of Innovation, Research & Development, Leadership in Education, ... This is the 9 th year of the ... of companies and individuals from past years . ... on a pre-described set of criteria, by a panel ...
Breaking Biology News(10 mins):