The long awaited alternative to TNF-alpha inhibitors has FINALLY been approved. More than TWO YEARS after ALL clinical trials were successfully completed and after more than eighteen months since Centocor submitted the New Drug Application for approval, the FDA (aka F'ing DelAy) is allowing patients with psoriasis to use Stelara, a marvelous new biologic.
It works on a completely different cytokine (immune signal) pathways. It blocks different immune signaling molecues--interleukin 12 and interleukin 23. Down regulating these two pathways is supposed to increase the number of T-regulatory cells in the body. T-regs turn down inflammation the main underlying problem in autoimmune disease (and many other conditions as well i.e. cardiovascular disease and even some cancers).
Of course Canada Health approved Ustekinumab (Stelara )a year ago as did the European Union.
In July of 2008 a panel of independent experts convened by FDA to assess Stellara recommended UNANIMOUSLY for approval to the F'ing DelAY. Now just a short (not!) fourteen months later the incompetents at the FDA finally will allow US citizens the right to use the medication.
Sorry to be bitter.
The STUPID and unnecessary delays of this needed NOVEL, FIRST OF ITS KIND medication in our country just demonstrates how very dysfunctional the FDA is.
Good news is we can use it now. One shot is supposed to last a whole month. Now the only problem is paying for that shot. I have read that in Canada--Centocor charges as much as $10,000! Gee, no problem--only $120.000 a year. Let's hope that Centocor will reduce the price in the US. I know I know Big Pharma reducing prices to consumers--like pigs flying I will only believe it when I see it. Perhaps health care reform will force down prices. Hope so.
Read more at this URL:
Here is the article:
FDA Approves Ustekinumab for Moderate to Severe Psoriasis
ROCKVILLE, Md -- September 25, 2009 -- The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara), a biologic product for adults who have a moderate to severe form of psoriasis.
"This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance," said Julie Beitz, MD, Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, Rockville, Maryland.
Three studies of 2,266 patients evaluated the biologic's safety and effectiveness.
The FDA approval was primarily based on 2 phase 3 studies in which a significantly higher proportion of patients receiving either ustekinumab 45 mg or 90 mg achieved at least a 75% reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12 compared with patients receiving placebo.
With every-12-week ustekinumab maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for 1 year.
Since ustekinumab 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 hospitalisation. 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.
The FDA is requiring a risk evaluation and mitigation strategy (REMS) for ustekinumab that includes a communication plan targeted to healthcare providers and a medication guide for patients.
SOURCE: US Food and Drug Administration.