David Stanton (Cork East, Fine Gael)
Link to this: Individually | In context

Question 154: To ask the Minister for Health and Children her views on the use of Tysabri; if new applications for the drug are currently being considered and allowed; and if she will make a statement on the matter. [17108/09]

Mary Harney (Dublin Mid West, Progressive Democrats)
Link to this: Individually | In context

Tysabri was licensed by the European Commission in June 2006 as a therapy for multiple sclerosis for the following patient groups:

Patients with high disease activity despite treatment with a beta-interferon, or

Patients with rapidly evolving severe relapsing remitting multiple sclerosis.

There are risks with this drug and Tysabri has been associated with Progressive Multifocal Leukoencephalopathy (PML) which is related to a virus in the central nervous system of immune-compromised individuals. As a result of this the drug is licensed to be administered under strict guidelines.

The therapy must be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and under strict clinical conditions. Tysabri 300 mg is administered by intravenous infusion once every four weeks. Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit within six months.

Data on the safety and efficacy of Tysabri beyond two years are not available. Continued therapy beyond this time should be considered only following a reassessment of the potential for benefit and risk.

The Irish Medicines Board as statutory body responsible for regulation of medicinal products in Ireland and in co-operation with the European Commission and European Medicines Agency, is keeping the status and other safety issues of this medicinal product under review.

Apart from the indications outlined above no other indications for Tysabri are permitted in any member state in Europe. I also understand from the Irish Medicines Board, that they are not aware of any other uses for the drug being considered at this time.