Tysabri moves towards European approval
28 Apr 2006
The European Medicines Agency (EMEA) has recommended that Tysabri (natalizumab) should be made available as a treatment for relapsing remitting multiple sclerosis (MS), to delay the progression of disability and reduce the frequency of relapses. The recommendation will be considered for final marketing approval by the European Commission. Its decision is expected during the summer.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said the drug should be used as single disease-modifying therapy either in patients with highly active relapsing remitting MS who have failed to respond to treatment with a beta interferon, or in patients who have rapidly evolving severe relapsing remitting MS.
Tysabri was originally approved by the US Food and Drug Administration (FDA) in November 2004 but its use was voluntarily suspended by Biogen Idec and Elan Pharmaceuticals in February 2005 after cases of the rare neurological disease progressive multifocal leukoencephalopathy (PML) were reported. An FDA advisory committee recently recommended that the drug should be reintroduced in the US.
In making its European recommendation, the CHMP reviewed available trial data and a comprehensive safety analysis, which included the assessments for cases of PML. It also reviewed a risk management plan to assess and minimize risks, including PML and other serious infections.
The European Commission is the final decision-making body for all centrally-reviewed medicinal products which are to be introduced in the EU market. Once licensed, the drug is also likely to be referred to NICE.
Ken Walker, acting chief executive of the MS Society, said, "We welcome the recommendation that Tysabri should be allowed to be prescribed in Europe and very much hope it will soon be available to people living with MS in the UK now that safety issues have been addressed.
"Trials have shown the drug can not only reduce MS relapses or 'attacks' significantly but also have a much greater impact on the progression of disability than other available treatments."
Tysabri was originally approved by the US Food and Drug Administration (FDA) in November 2004 but its use was voluntarily suspended by Biogen Idec and Elan Pharmaceuticals in February 2005 after cases of the rare neurological disease progressive multifocal leukoencephalopathy (PML) were reported. An FDA advisory committee recently recommended that the drug should be reintroduced in the US.
In making its European recommendation, the CHMP reviewed available trial data and a comprehensive safety analysis, which included the assessments for cases of PML. It also reviewed a risk management plan to assess and minimize risks, including PML and other serious infections.
The European Commission is the final decision-making body for all centrally-reviewed medicinal products which are to be introduced in the EU market. Once licensed, the drug is also likely to be referred to NICE.
Ken Walker, acting chief executive of the MS Society, said, "We welcome the recommendation that Tysabri should be allowed to be prescribed in Europe and very much hope it will soon be available to people living with MS in the UK now that safety issues have been addressed.
"Trials have shown the drug can not only reduce MS relapses or 'attacks' significantly but also have a much greater impact on the progression of disability than other available treatments."
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