Posted on 01/14/2008 3:05:11 PM PST by shrinkermd
Tysabri was pulled from the market in 2005 after three patients in clinical trials contracted a brain infection known as progressive multifocal leukoencephalopathy, and two patients died. Two patients were also taking Avonex. However, the FDA allowed the drug to return to the market in 2006 with a risk-management program.
Crohn's disease is a chronic, progressive disease marked by inflammation of the bowel. The condition often causes abdominal pain and bleeding and can require surgery to remove diseased portions of the intestine. About 600,000 Americans have the disease.
It wasn't immediately clear if there are any conditions attached to Tysabri's approval, but the agency was expected to limit the approval for use in patients who have failed other therapies for Crohn's disease.
The FDA will discuss the approval at a 4 p.m. press conference.
Last July, the FDA's gastrointestinal drug and drug safety advisory committees recommended the agency approve the drug under certain conditions including a requirement that Biogen and Elan keep studying the drug in Crohn's patients. In October, the FDA delayed a decision on Tysabri until this month. So far, European regulators have declined to approve Tysabri for use in Crohn's patients.
Earlier this month, Biogen Idec said more than 21,000 patients were using Tysabri and so far there haven't been any additional reports of PML. However, both the FDA and the companies have said they expect cases of PML to crop up over time
(Excerpt) Read more at online.wsj.com ...
A guy I grew up with died of Crohn’s Disease. Hope this helps in treatments.
This is puzzling. Natalizumab (Tysabri) is also highly effective as a treatment for Multiple Sclerosis, but no mention of it in the article. In MS, natalizumab was shown to reduce relapses by 67% vs. a placebo. It slowed the progression of disability by 42%.
Importantly: “The wholesale price of Tysabri is US $2184.62 per vial. Given that natalizumab is generally administered 13 times a year, the annual costs for Tysabri is approximately US $28,400 (not including costs associated with infusion services), priced at a premium to the older generation drugs.”
Other bits: There are about half a dozen major drugs coming through the process right now that address a different characteristic of Crohn’s disease. They are all Tumor Necrosis Factor-1 (alpha) inhibitors. Several are showing tremendous possibilities in not just treating Crohn’s, but also treating rheumatoid arthritis, ankylosing spondylitis, psoriasis and psoriatic arthritis, and refractory asthma.
Thanks for the detailed and timely information. Excellent.
The WSJ did mention the use of this drug in MS—”...Tysabri, sold jointly by Elan Corp. and Biogen Idec Corp., was previously approved in 2004 as a treatment for multiple sclerosis and is available under a restricted distribution system designed to monitor patients for a rare brain infection and other side effects..”
I could only excerpt at most 300 words.
I have Crohn’s. It nearly killed me in the fall of 2005, and I had to undergo major abdominal surgery to just survive. Not fun, and life altering in the extreme!
If you haven’t already looked up TNF-1 drugs, do so. They are having some incredibly good results with them. Some of the names to look for are Adalimumab (brand name Humira), Infliximab (brand name Remicade), and Etanercept (brand name Enbrel). Other things to look for include Certolizumab Pegol, Enzyme A20, Interleukin-6, and even hot-pepper Capsaicin are being investigated for TNF-1 inhibition.
Related TNF-1 news:
It’s too late for me, but since Crohn’s is likely genetic, at least my son and/or grand kids (when they come in the distant future) will have better options for treatment.
Wow! Thanks for the link! I always liked Steele, and his message is very inspirational.
ping
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