FDA hesitant to OK Biogen, Elan drugs

By MATTHEW PERRONE, AP Business Writer Fri Jul 27, 6:35 PM ET
WASHINGTON - Federal health officials on Friday said they are hesitant to allow a drug made by Biogen Idec Inc. and Elan Corp. to be used to treat an intestinal disorder because of potentially fatal side effects.
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The Food and Drug Administration said it is concerned patients taking Tysabri, which is already approved to treat multiple sclerosis, could develop a rare and incurable nervous system disease that is usually fatal after six months.
Biogen, which codeveloped the drug with Elan, is asking the agency to approve Tysabri to treat Crohn's disease, which causes inflammation of the intestines and affects about 1 million people worldwide.
FDA posted its review of the drug ahead of a Tuesday meeting where outside experts will vote on whether the drug should be approved. The government is not required to follow the experts' advice, though it usually does.
The use of Tysabri to treat multiple sclerosis, a neurological disease, has been restricted since three patients who used the drug developed the rare nervous system disorder known as multifocal leukoencephalopathy, or PML.
The drug was temporarily pulled from the market in February 2005. FDA decided to put the drug back on the market last year under the condition that patients use it alone, and not in combination with drugs used to suppress the immune system. FDA determined that combining Tysabri with these treatments could increase risk of PML.
In its review of Tysabri for the new use, FDA said it would be more difficult to assure the safety of the drug in patients with Crohn's Disease, since they are more likely to take immune-system suppressing drugs as additional therapy.
Government reviewers also said Biogen did not conduct several safety analyses that FDA had requested. And many safety analyses the company did submit only tracked patients over a short time rather than over the long-term.
Despite these safety concerns, FDA said the drug appeared to be effective in preventing inflammation of the intestine wall in Crohn's Disease patients.
If approved for the new use, Tysabri could have sales over $300 million per year, according to Bear Stearns analyst Mark Schoenbaum. The drug would compete with Remicade, the leading Crohn's treatment made by Johnson and Johnson.
Biogen posted a profit of $217.5 million in 2006, while Dublin, Ireland-based Elan Corp. posted a $267.3 million loss.
Shares of Biogen Idec Inc. fell $1.18, or 2 percent, to $57.01 Friday. Shares of Elan Corp. plc fell 73 cents, or 3.7 percent, to $19.