Elan and Biogen have gained another regulatory victory in their effort to return Tysabri to the market, winning European approval for use of the drug to delay progression and reduce the frequency of relapses. The FDA recently allowed the use of Tysabri as a second-line therapy for patients who hadn't responded to other therapies. When Tysabri was introduced, researchers believed that it represented a major advance for MS patients, but the drug was quickly pulled after it was linked two several cases of a rare brain disease. Regulators seem content to allow it back on the market, so long as patients have been made aware of the potential risks and rewards Tysabri offers.
- here's the AFX report in Tysabri