Tysabri to be allowed as a Crohn's Disease therapy in the US, not Europe

The_Conductor

From the Boston Globe (not sure why its not been reported locally?)

http://www.boston.com/business/globe/articles/2007/08/01/fda_panel_backs_tysabri_for_crohns/

A panel advising the Food and Drug Administration yesterday said the multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland, should be approved to treat Crohn's disease.

The recommendation came just six weeks after the European Medicines Agency rejected the two firms' application to use Tysabri as a treatment for Crohn's. The European agency said clinical studies did not show the drug's benefits outweighed its risks.

In a 12-3 vote yesterday afternoon, the panel said Tysabri is effective in easing the symptoms of Crohn's -- an inflammatory disorder of the bowel -- in patients who don't respond to steroids or immunosuppressants.

The joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended the drug be used only for those with moderate to severe symptoms, and with strict controls. Two committee members abstained from the vote.

Like multiple sclerosis, Crohn's is an autoimmune disease in which the body's defenses attack otherwise healthy tissue. About 600,000 people in the United States suffer from Crohn's, which can cause abdominal pain and bleeding.

The FDA does not have to fol low the recommendation, although the agency tends to follow the advice of its medical panels. A final ruling could come within weeks.

Biogen Idec shares gained $1.11, or 2 percent, to close at $56.54 in regular trading -- before the vote was taken -- and rose as high as $57.72 in after-hours trading. Elan shares gained 70 cents or nearly 4 percent in regular trading, closing at $18.73. They shot up as high as $19.75 in after-hours trading.

Tysabri has had a troubled history since it was first approved in November 2004. A few months later, Biogen Idec and Elan found the drug was linked to a rare brain disease. Three patients in clinical trials contracted the disease, known as progressive multifocal leukoencephalopathy, and two died. But two of the patients were also taking Biogen Idec's multiple sclerosis drug Avonex, and a third had taken other immunosuppressants. That led some researchers to conclude the risks are low if Tysabri is taken by itself.

The drug went back on sale in June 2006 after an extensive safety review. It is now recommended only for MS patients who don't respond to other treatments. A registry has also been established to track patients and watch for signs of the brain disease.

Elan has taken the lead in developing Tysabri as a treatment for Crohn's, and officials from the company presented its case to the FDA advisory committee.

"There's a big unmet need in Crohn's disease for the most severe patients who fail other therapies," William Sandborn, professor of medicine in gastroenterology at the Mayo Clinic and a Tysabri researcher, told the panel. "We need new treatments."

David Feigal, Elan's senior vice president for regulatory affairs, said, "Tysabri can offer people with Crohn's disease a new treatment option when others have failed." Feigal added that the company believes Tysabri "has a favorable risk-to-benefit profile to support approval."

When Tysabri was first developed, it was viewed as a major advance for many MS patients because it proved more effective in preventing flare-ups than existing treatments. But in Crohn's patients, the drug wasn't "clearly distinguished" from other approved Crohn's treatments, according to FDA documents presented at the meetings.

Tysabri hasn't developed into the blockbuster that Elan and Biogen Idec were hoping for at its introduction. After returning to the market last summer, the drug has sold modestly, in part because of the strong safety warnings it carries and the strict controls that limit its distribution. If the FDA approves Tysabri for Crohn's, sales of the drug would likely only grow incrementally because of the likely limits on its use.

The_Conductor

http://www.newscientist.com/channel/health/mg19526135.600-unusual-bacteria-may-trigger-crohns-disease.html

CROHN'S disease might be caused by bacteria that have borrowed a few nasty genes from, of all things, bubonic plague.

Crohn's is an incurable inflammation of the intestine that affects 1 in 1000 people in Europe and North America. Researchers suspected gut bacteria were to blame, but could not be sure which, as tests often produced contradictory results. Now Ken Simpson and colleagues at Cornell University in Ithaca, New York, have discovered a possible reason for the confusion.

When they studied bacteria from the guts of people with inflamed small intestines, they found no evidence of MAP, a bacterium that some have blamed for Crohn's. MAP is related to the TB bacterium.

However, they did find higher than normal levels of the common gut bacteria E. coli in more inflamed areas. These E.coli uniquely carry disease-related genes from a host of other pathogens, including salmonella, cholera and bubonic plague, as well as from strains of E. coli that cause disease outside the gut (The ISME Journal, DOI: 10.1038/ismej.2007.52).