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. ....full
report in Medical News Today
