EU recommends restricted availability

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

EU recommends restricted availability

Postby Dunmann » Fri Apr 28, 2006 5:37 am

Recommendations on Tysabri release restriction

28 April 2006 11:56

The European Medicines Agency (EMA) has recommended that the multiple sclerosis treatment drug, Tysabri, should be made available to patients on a restricted basis.

Tysabri was withdrawn from the market early in 2005 after some US patients who had been treated with the drug in combination with other medication developed the brain disease, PML.

The decision led to the collapse of Élan's share price.

Since then the regulatory authorities in the US and in Europe have been separately re-examining the clinical trail research data surrounding the drug's original launch.

Today's recommendation will go before the European Commission for final approval. That is expected in June but will limit the use of Tysabri as a single therapy only which will be restricted to patients with an aggressive form of Multiple Sclerosis.

Today's announcement from the EMA could mean Tysabri will launch in Europe before any relaunch in the US where the Food and Drug Administration has still to give final marketing approval.

Élan's share price has risen by more than 68c, or 5.8% in Dublin to €12.33 on the Dublin market following the announcement.
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Re: EU recommends restricted availability

Postby HarryZ » Fri Apr 28, 2006 5:42 pm

Today's recommendation will go before the European Commission for final approval. That is expected in June but will limit the use of Tysabri as a single therapy only which will be restricted to patients with an aggressive form of Multiple Sclerosis.


This is interesting....Tysabri was not tested on aggressive forms of MS and has, to my knowledge, not been recommended for this type of the disease. Has anyone heard differently?

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