The European Medicines Agency has recommended additional measures to better manage the risk of progressive multifocal leukoencephalopathy (PML) with Elan Pharma’s Tysabri (natalizumab).
The CHMP has concluded that the risk of developing PML increases after two years of Tysabri use, though this risk remains low.
However, 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.
Because it is important that PML is detected early, the Committee recommended that a number of measures be put in place to ensure that patients and doctors are fully aware of the risk of PML.
These include an updating of the product information to include the increased risk of PML after two years of treatment and forms to be signed by patients at the beginning of treatment, and again after two years, after in-depth discussion about the risk of PML with their doctor.
Measures to minimise the risk of PML were part of the initial marketing authorisation for Tysabri, issued in June 2006. Since then, they have been continuously updated and strengthened to increase awareness of the risk of PML.