FDA, Biogen mull Tysabri label changes

The FDA is huddling with Biogen Idec and Elan on amendments to Tysabri's label. The reason, of course, is the news of two cases [1] of the brain disorder progressive multifocal leukoencephalopathy, or PML, that emerged in late July.

In a notice on the agency's website, the FDA reiterated [2] its belief that Tysabri taken on its own may generate a smaller risk of PML than when it's taken in combo with other meds that alter the immune system.

Compared with the response the last time PML emerged in Tysabri patients, it's mild. As you know, Tysabri was pulled from the market when PML first cropped up, but was allowed back [3] on the market on a strict risk-management program, under which patients using the drug are monitored for infection. Investors showed their relief by pushing Biogen shares up by about 2 percent to $53.48, and Elan shares by 5 percent, to $14.25.

- check out the release [2]
- read the Wall Street Journal story [4]
- see the item [5] in the Wall Street Journal Health Blog

Related Articles:
Biogen: Tysabri patients have PML [1]
Analysts: Tysabri scrips will suffer [6]
Biogen CEO: Tysabri to reach $1B in 2008 [7]
Biogen CEO: Tysabri patients will get PML [8]
After reintroduction, Tysabri builds patient base [9]