[Deepak]

HORSHAM, Pa., September 25, 2009 -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA™ (ustekinumab) for the treatment of adult patients 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The efficacy and safety of STELARA were evaluated in one of the largest clinical development programs for a biologic medication in the treatment of psoriasis.

STELARA is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.

"Findings from clinical studies showed that approximately seven out of 10 patients receiving STELARA achieved 75 percent skin clearance after just two doses, and maintained response for one year with continued treatment," said Mark Lebwohl, MD, professor and chairman of the Department of Dermatology, The Mount Sinai School of Medicine, and study investigator. "STELARA is a meaningful new option for patients with psoriasis that offers maintenance dosing every 12 weeks following two starter doses."

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 7.5 million Americans have psoriasis, which can present in various forms, ranging from mild to severe and disabling.

The clinical development program for STELARA included more than 2,200 patients, with two pivotal Phase 3 trials serving as the primary basis for FDA approval. In each of these trials, a significantly higher proportion of patients receiving either STELARA 45 mg or 90 mg achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI), or PASI 75, at week 12 compared to patients receiving placebo. With every-12-week STELARA maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for one year.

STELARA is a subcutaneous injection given at weeks 0 and 4, followed by every-12-week dosing. The recommended starting dose of STELARA is 45 mg for patients weighing 220 lbs. (100 kg) or less, and 90 mg for patients weighing more than 220 lbs.

"We are pleased to be in the position to make STELARA available to patients living with this chronic, lifelong inflammatory disease and for dermatologists treating these individuals," said Kim Taylor, President, Centocor Ortho Biotech Inc. "We have collaborated with the FDA to ensure that STELARA is supported by a Risk Evaluation and Mitigation Strategy, which will allow physicians to make treatment decisions based on the most comprehensive risk-benefit information. Importantly, we have already compiled three years of safety data from our ongoing five-year extension studies, which will aid in establishing the long-term safety profile of STELARA."

"Psoriasis is a serious disease that affects millions of Americans," said Randy Beranek, President and CEO of the National Psoriasis Foundation. "The approval of STELARA represents an important new treatment option for people who are living with this chronic condition."

Details Here: http://www.centocororthobiotech.com/...tle=PR_Stelara

[vencasand]

by the way deepak, the cost of this or should i say the awp of this in the us is $5828.75. guess i will never get to use it. but at least someone is trying to help people with psoriasis

[Deepak]

Originally Posted by vencasand

by the way deepak, the cost of this or should i say the awp of this in the us is $5828.75. guess i will never get to use it. but at least someone is trying to help people with psoriasis

wow was that for a whole year or single shot..?

Drugs.com Quotes

Since Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

[vencasand]

1 injection of the 45mg shot!!!!!! not cheap.

[Deepak]

Originally Posted by vencasand

1 injection of the 45mg shot!!!!!! not cheap.

Wow Thats expensive, Well its for rich peoples then.. Hope price will drops down..

[Ashma]

Does that shot permanently get rid of psoriasis ?

[vencasand]

the treatment is on going. there is so many side effects. it gets rid of it as long as you use it. i don't know if medical insurance would cover it. because of the side effects i don't know if i would even want to try it if it were cheap. but it is a step in the right direction at least they are working on the psoriasis issue.

[MaryMary]

Rich person drug, its expensive and still have side effects,so what is the use. Many people won't afford, but people would buy if its 100% successful.