Elan launches trials on Tysabri

ELAN and its partner Biogen Idec have begun a new trial on patients of the multiple sclerosis drug, Tysabri, banned from the market in February 2005.

That followed the deaths of two patients, who contacted a rare brain disease.

Company shares rose 18 cent to €12 on the news.

The drug is expected to be cleared for return to the market by the US Food and Drugs Administration (FDA) by the end of June 2006, following applications by the two companies to have the drug reinstated.

The companies’ application for approval of Tysabri as a treatment for MS is also under review with the European Medicines Agency.

Tysabri was beneficial to thousands of MS sufferers, but was withdrawn after the deaths of two patients last year. Following positive fresh trials the FDA is expected to allow the drug back to the market, provided risks to users are highlighted.

Tysabri sales were suspended when three patients developed a rare brain and spinal-cord infection known as progressive multifocal leukoencephalopathy, or PML.

Two of the three died and in two of the cases, patients were also taking another Biogen drug, Avonex, at the same time. That led to speculation that Tysabri alone might be less risky.

Biogen, in a recent statement said, Tysabri was highly effective and MS patients should be able to decide for themselves whether the drug’s risks are acceptable.

Yesterday both companies said they have completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS.

The latest study is open to patients who had previously participated in the Phase III MS trial and the subsequent safety evaluation programme. It is expected that roughly 1,500 patients will come forward.

The trial will is set run for one year.