Guest guest Posted June 6, 2006 Report Share Posted June 6, 2006 Monday, June 5, 2006 FDA re-approves Tysabri The Food and Drug Administration today gave Biogen Idec the go-ahead to resume sales of Tysabri, the multiple sclerosis drug that was pulled off the market 16 months ago when patients in clinical trials developed unexpected side effects. Prescribing language from the FDA means Tysabri is more likely to be prescribed only to those patients who have responded poorly to existing therapies or otherwise need to try another drug. Patients taking Tysabri will have to participate in a safety and monitoring program, known by the acronym Touch. Posession of the drug will be tightly controlled from manufacture until it is administered. Patients will have to get brain scans before they start on the drug, so doctors can distinguish the progression of their multiple sclerosis from the possible development of a potentially deadly disease that showed up in three patients taking Tysabri in clinical trials. "First we have to educate everybody on the Touch program," said C. Mullen, Biogen's chief executive. "We have to help people through what is a litle bit of an onerous and cumbersome process. If you want to be on the product, you have to work your way through." Doctors and other healthcare professionals will also have to go through training under the new safety program. Head of Development Dr. Burt Adelman said the the first doctors should be ready to administer Tysabri in early July. It could take several more months before an estimated 2,000 infusion centers are ready to treat patients. The drug is administered in a monthly intravenous infusion.Tysabri was approved only as a monotherapy, meaning it cannot be used in combination with any other MS treatment. Two of the three patients that developed the potentially deadly brain disease in clinical trials were also taking Avonex, another MS treatment made by Biogen Idec. Stocks of Biogen Idec and its partner in Tysabri, Elan Corp. of Ireland, both dropped on the news, perhaps indicating that investors had hoped the drug would be approved unambiguously for first-line treatment. At 1:30, Biogen Idec shares were down $1.04 to $46.67, and Elan shares were down $1.16 to $17.82, a drop of about 6 percent. (By Krasner, Globe Staff) Posted by Boston Globe Business Team at 01:49 PM Print | E-mail to a friend | Permalink | Subscribe via rss More news updates from The Boston Globe Quote Link to comment Share on other sites More sharing options...
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