Irish drug company Elan has started selling its multiple sclerosis drug Tysabri in several European countries, including Ireland, for the first time and has resumed sales in the US following a 16-month long suspension caused by the deaths of people taking the drug.
Approval to sell the drug in both Europe and the US was granted last month by the relevant authorities, though certain restrictions were imposed. Tysabri, which was produced in a joint venture between Elan and Biogen Idec, was withdrawn from US shelves just four months after its accelerated approval in November 2004 when two patients taking it in conjunction with other drugs died and a third fell seriously ill from a rare brain disease. The drug never even made it to market in Europe.
Elan said yesterday the drug is now available in Ireland, the UK, Germany, Sweden and the US. Its shares fell 15 cent, or 1.4 per cent, to €10.55 in Dublin yesterday.
Under the terms of the approval agreements, Elan is required to issue so-called alert cards to all its European users, in addition to educating patients and physicians about the drug. Meanwhile in the US, the company has had to revise the drug's labelling and implement a risk-management plan, known as touch, whereby Elan has agreed a contract with a single distributor and 12 speciality pharmacies.
A spokeswoman was unable to confirm whether the drug was already in use in Ireland.
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