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FDA advisory committee recommends Tysabri should be reintroduced
09 Mar 2006
An advisory committee to the US Food and Drug Administration (FDA) has unanimously recommended that Tysabri (natalizumab) should be reintroduced for the treatment of relapsing remitting multiple sclerosis in the US. The FDA is expected to make its final decision by the end of March. It usually follows advisory committee recommendations.
Tysabri was originally approved by the FDA in November 2004 for the treatment of MS, 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. The advisory committee’s recommendation stipulates that patients should be registered and monitored.
Mike O’Donovan, chief executive of the MS Society, said, “We welcome the recommendation and very much hope Tysabri will soon be available to people living with MS in the UK.
“Recent trial results 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.
“Safety must, however, be a priority for both neurologists and patients and it is absolutely right for the committee to have made its recommendation conditional on careful monitoring to minimise the small risk which has been identified.”
Before the drug could become a licensed treatment in the UK, it would need approval from the European Agency for the Evaluation of Medicinal Products. Once licensed, it would also be likely to be referred to NICE.
The committee’s recommendations for approval in the US include:
• Tysabri being made available only to patients diagnosed with relapsing MS who have enrolled along with their physicians in a mandatory registry programme
• the drug being given only at authorised infusion centres where the medical personnel have been trained in its proper use and in the risks of PML
• Tysabri not being used in patients who have compromised immune systems or who are taking other immunosuppressive or immunomodulatory agents, with the possible exception of periodic steroids to treat relapses
• prescribing information carrying a warning about PML
• before starting treatment, the physician must complete a ‘patient checklist’ to ensure that the patient meets all requirements for use of Tysabri and, before to each infusion, the patient and infusion nurse complete a checklist to screen for symptoms suggestive of PML
The advisory committee did not reach a consensus on whether Tysabri should be used as a ‘first-line’ therapy or whether a patient must first be on another disease-modifying therapy which proved ineffective.
Mike O’Donovan, chief executive of the MS Society, said, “We welcome the recommendation and very much hope Tysabri will soon be available to people living with MS in the UK.
“Recent trial results 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.
“Safety must, however, be a priority for both neurologists and patients and it is absolutely right for the committee to have made its recommendation conditional on careful monitoring to minimise the small risk which has been identified.”
Before the drug could become a licensed treatment in the UK, it would need approval from the European Agency for the Evaluation of Medicinal Products. Once licensed, it would also be likely to be referred to NICE.
The committee’s recommendations for approval in the US include:
• Tysabri being made available only to patients diagnosed with relapsing MS who have enrolled along with their physicians in a mandatory registry programme
• the drug being given only at authorised infusion centres where the medical personnel have been trained in its proper use and in the risks of PML
• Tysabri not being used in patients who have compromised immune systems or who are taking other immunosuppressive or immunomodulatory agents, with the possible exception of periodic steroids to treat relapses
• prescribing information carrying a warning about PML
• before starting treatment, the physician must complete a ‘patient checklist’ to ensure that the patient meets all requirements for use of Tysabri and, before to each infusion, the patient and infusion nurse complete a checklist to screen for symptoms suggestive of PML
The advisory committee did not reach a consensus on whether Tysabri should be used as a ‘first-line’ therapy or whether a patient must first be on another disease-modifying therapy which proved ineffective.
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