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European drugs watchdog finds benefits of Tysabri continue to outweigh risks
25 Jan 2010
The European Medicines Agency (EMA) has finalised a review of Tysabri (natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the JC virus.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk of developing PML increases after two years of use of Tysabri although this risk remains low.
It also stated, however, that the benefits of the medicine continue to outweigh its risks for patients with highly active relapsing-remitting multiple sclerosis, for whom there are few treatment options available.
As a result of the review, the Committee recommended a number of measures be put in place to ensure that patients and doctors are fully aware of the risks of PML.
These include:
Read more about Tysabri (natalizumab)
It also stated, however, that the benefits of the medicine continue to outweigh its risks for patients with highly active relapsing-remitting multiple sclerosis, for whom there are few treatment options available.
As a result of the review, the Committee recommended a number of measures be put in place to ensure that patients and doctors are fully aware of the risks of PML.
These include:
- an update of the product information to add information about the increase in the risk of PML after two years of treatment and additional advice on how to manage patients who show signs of PML;
- forms to be signed by patients at the beginning of treatment with Tysabri, and again after two years of treatment, after in-depth discussions about the risk of PML with their doctor.
Read more about Tysabri (natalizumab)
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