Elan and Biogen Idec’s Tysabri gets EU approval

Elan and Biogen Idec have revealed that the European Commission has granted authorisation for Tysabri to be marketed for the treatment of relapsing and remitting multiple sclerosis (MS).

The drug had previously been withdrawn following safety concerns after two patients contracted a rare and often fatal brain disease, progressive multifocal leukoencephalopathy, when using the drug.

Both companies suffered adversely from the drug’s withdrawal, with Elan’s shares dropping from $18.90 (10.40 pounds) to $8.00 on announcement of the withdrawal.

However, Elan and Biogen Idec say the drug’s new approval following the results of new phase III trials demonstrating Tysabri’s efficacy and safety represents a new opportunity for MS patients.

James C Mullen, chief executive officer of Biogen Idec, remarked: “Today marks an important step forward for the European MS patient community. Tysabri represents one of the most significant advances in MS treatment in nearly ten years and provides patients living with this disabling disease an important new therapeutic choice.”

Elan’s president and chief executive officer, Kelly Martin, added: “This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative.”

The drug has also be re-approved in the US, although with added warnings about the possible risks of taking the drug.

Dr Roger Williams, medical director of the Northern Rockies MS Centre in Montana, told the US Multiple Sclerosis Foundation: “The risks and cost of Tysabri have to be judged against those of inadequate treatment of active MS.”

“Patients and their doctors will have to decide these thorny issues on a case-by-case basis. Now, at least, they have that option,” he concluded.

Some 85,000 Britons are thought to suffer from the disease, caused by damage the myelin coating of nerves, according to the Multiple Sclerosis Society.

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