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NEWS FROM THE American Association of Neurology ANNUAL MEETING

Posted Jan 14 2009 8:25pm
April 30th, 2008 - Rec'd from the MSF newsletter:

The American Academy of Neurology met in Chicago April 12 through April 19 for its 60th Annual Meeting. The following two news briefs were among the information presented.

- Tysabri -
There have been no further cases of progressive multifocal leukoencephalopathy (PML) linked to Tysabri since its re-launch, Biogen Idec and Elan Corporation announced.

The companies also said clinical trials showed relapses and disability progression were significantly less likely in people taking the disease-modifying drug than in those taking placebo.

As of March, about 15,300 people in the U.S. were on the therapy, which also is now being used to treat Crohn's Disease. About 3,600 people have been on Tysabri for 18 months or longer.

Dr. Ben Thrower, medical advisor to the Multiple Sclerosis Foundation, said the updated safety information is helpful, and to a certain degree reassuring, but doesn't answer all the safety questions about Tysabri.

Previous cases of PML were seen at 18 months in people who were taking Tysabri/ Avonex combination therapy. It is important to look at those who have been on the drug for that amount of time or longer, Thrower said. It is possible PML could be associated with Tysabri as a monotherapy but that it takes longer to show itself.

"Tysabri is an important drug to have in our toolbox of options," he said. "But I'm not comfortable with the idea that it is significantly more effective than other available disease-modifying drugs."

Rebif, Betaseron and Copaxone all did well during recent clinic trials, he added.

"The importance of Tysabri may not be that it is better than Avonex, Betaseron, Copaxone and Rebif, but that it is different in how it works," he said.

In the United States, Tysabri is only available at approved infusion sites to patients enrolled in the Touch Prescribing Program.

- Fingolimod -
Researchers reported good results in clinical trials of the oral medication fingolimod, saying more than 67 percent of participants who took the drug for three years were relapse-free.

Of the 173 people who stayed with the trial for three years, 67 percent hadn't had a relapse at the end of the three-year period, according to a study supported by Novartis, which makes fingolimod. MRI scans showed 89 percent of the participants showed no disease activity; 75 percent of those in the clinical trial showed no new or newly enlarged lesions, according to the trial's reported results.

The drug for relapsing-remitting MS is taken once a day. Side effects seen in the trial included headache, fatigue, flu and cold symptoms.

Fingolimod, also called FTY720, is an immune-modulating drug. It binds to immune cells and keeps them in the lymph nodes.

A third phase of study on the drug is ongoing and expected to be completed in July 2009.

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