The European Medicines Agency (EMA) had some concerns and was of the provisional opinion that Natalizumab could not be approved for treating patients with relapsing-remitting multiple sclerosis that is not highly active and who do not have antibodies against the JC virus.
Source: EMA (Q&A below)
"In my opinion this is a great pity. Natalizumab is probably the most effective DMT we have in appears to have a favourable risk profile in the JCV seronegative group. This means MSers have to fail 1st-line DMTs, by having highly-active MS, before accessing Natalizumab. Therefore there is no filling in of the hole in the doughnut yet; not with fingolimod nor natalizumab. When are the regulators going to move on this? MS is a brain shredder; the sooner MSers get access to highly-effective therapies the better."
CoI: multiple
Labels: EMA, Natalizumab, PML