Ustekinumab delayed AGAIN by the FDA

Last Friday the FDA in again delayed the most significant advance in the treatment of autoimmune disease in last five years. The drug called CNTO1275 in research labs, Ustekinumab by doctors and Stelara by patients.

This drug, Ustekinumab, had "stunning" results according to independent observers in human clinical trials announced in Spring of 2007.

When I first read of the results, I naively thought that the FDA would rush this new drug to the market. After all Ustekinumab targeted a part of the immune system that no other drug targeted. It was new. It was novel. It was remarkably efficacious. I thought FDA would have it approved by summer of 2006.

But no. The FDA required the drug manufacturer to turn in a Biologic License Application. It took Centocor the manufacturer until Dec 5 2007 to get application in order. It took the FDA until March 2008 to DECIDE to accept the application. It took until June of 2008 to get together a outside science panel to review data. The independent panel recommended UNANIMOUSLY to approve the medication. FDA sat on the recommendation for six weeks then announced they would delay another four months until December 2008--TWENTY MONTHS AFTER THE STUNNING RESULTS IN 2006.

My son has been crippled and frozen sitting in a wheel chair for all those twenty months. Now the FDA rhymes with DELAY. DELAY. DELAY. has postponed approval AGAIN! B@$TARDS! I wish those evil monsters could spend one day in my son's place. Just one day of pain and terrible limitations needing help to do every single necessity of daily life. PIGS! I need a shoe to throw at their heads.

Did I mention in September of 2008 clinical trial results were announced indication that Ustekinumab beat for efficacy the number one drug on the market (Enbrel) for my son's conditions (psoriasis, PsA, AS) in head to head trials?

Is someone getting at the FDA getting paid off to delay this drug?

Read the article here:http://www.biospace.com/news_story.aspx?StoryID=121056&full=1



FDA Holds Off Decision on Johnson & Johnson (JNJ) Psoriasis Drug
12/19/2008HORSHAM, Pa., Dec. 19 /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.

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 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.
Source: Centocor, Inc.