Curious, it took nearly a week for this post to get from Comcast to Yahoo:
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This drug keeps leukocytes from migrating into the body's organs, at a
cost of about US$28,400 per year. I gather this will be yet another
expensive medication for Crohn's that reduces inflammation at the expense
of capacity of the immune system to fight infections.
On Mon, 28 Jan 2008 19:08:39 -0700, Dale <dale@...> wrote:
> BACKGROUND (article follows), According to Wikipedia (wfiw):
>
> "...Natalizumab [aka Tysabri] is the first alpha-4 antagonist in a new
> class of agents called selective adhesion-molecule (SAM) inhibitors.
> Alpha-4 integrin is required for leukocytes to migrate into the body's
> organs such as the brain and gut; natalizumab prevents leukocytes from
> doing that."
>
> "...In these trials[1][2], natalizumab was shown to reduce relapses in MS
> patients by 68% vs. a placebo, a margin far greater than had been seen
> for
> other approved MS therapies."
>
> "...Also in these trials natalizumab slowed the progression of disability
> (as measured by EDSS) by approximately 50% [3] (the US and EU medical
> authorities use slightly different measures of disability progression,
> and
> use values of between 42% and 54%)."
>
> "...In Crohn's, a randomized controlled trial found that natalizumab
> increased the rate of remission."
>
> "...Two further randomized controlled trials have confirmed natalizumab's
> effectiveness in increasing the rate of remission and in maintaning
> remission in Crohn's."
>
> "...the annual costs for Tysabri is approximately US$28,400 (not
> including
> costs associated with infusion services)..."
>
> Tysabri had been withdrawn from the market after the occurance of a rare
> brain disease in two patients taking the drug.
>
> <http://en.wikipedia.org/wiki/Natalizumab>
>
> -- Dale
> <http://DaleRoose.com>
> If a small improvement in the DNA of cattle could give them the power of
> speech, would that genetic modification be allowed?
> - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
> - -
> - - -
>
<http://www.boston.com/business/globe/articles/2008/01/15/biogen_idecs_ms_drug_o\
kd_for_crohns_disease/>
>
> Biogen Idec's MS drug OK'd for Crohn's disease
>
> But approval includes warnings on safety
>
> By Todd Wallack
> Globe Staff / January 15, 2008
>
> Federal regulators yesterday gave Biogen Idec Inc. good news about one of
> the Cambridge biotech company's key drugs.
>
> Tysabri, a treatment for multiple sclerosis, won approval from the Food
> and Drug Administration to be used against another debilitating illness,
> Crohn's disease.
>
> The move comes six months after an FDA advisory panel voted 12 to 3 to
> recommend the drug's approval to treat some forms of Crohn's, a chronic
> inflammatory disease of the intestinal tract. FDA officials said the
> final
> decision was delayed because Biogen Idec and Elan Corp., the Irish
> company
> that comarkets the drug, made changes to their application for a Crohn's
> approval.
>
> European regulators recently rejected a similar request to use the drug
> as
> a Crohn's treatment, arguing the risk of infection outweighed the
> relatively modest benefit of Tysabri.
>
> Biogen Idec temporarily shelved the drug three years ago after it was
> linked to a rare brain disease. The company says there have not been any
> additional cases of the disease since sales resumed in 2006, with new
> guidance on how it should be used. But some doctors remain wary of the
> treatment, even though it has been shown to be highly effective in some
> patients.
>
> Despite the safety concerns, Biogen Idec has predicted Tysabri will
> eventually become a major source of revenue. This month, the company
> reaffirmed predictions it will be used by 100,000 patients by the end of
> 2010, up from more than 21,000 at the end of 2007.
>
> Biogen Idec shares rose late in the day after the FDA news was released.
> The shares finished up 96 cents to $59.98, a gain of 1.6 percent.
>
> Doctors already had permission to use the drug to treat Crohn's disease
> on
> their own, but Biogen Idec needed formal approval to start marketing the
> drug for that purpose.
>
> The FDA decision does carry some caveats. Specifically, the agency
> approved the drug to treat patients with moderate to serious cases of the
> disease who can't be treated effectively with other drugs, such as
> steroids. The label will also carry safety warnings to reduce the risk
> that patients will contract the brain disease or other infections.
>
> About 500,000 people in the United States suffer from Crohn's, but it is
> unclear how many of them will qualify to use Tysabri. The disease
> frequently causes diarrhea and abdominal cramps; symptoms can also
> include
> fever, bleeding, and weight loss. There is no cure.
>
> Biogen Idec and Elan said they expect the drug to be available for
> Crohn's
> patients by the end of February.
>