European Commission approves wider use of Gilenya® (fingolimod), the first once-daily pill for multiple sclerosis
Novartis is delighted to announce that the European Commission has endorsed the Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Gilenya® (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis (RRMS).1
The indication expansion will now give clinicians the flexibility to use fingolimod in the highly active RRMS group, for patients needing to switch from interferons as well as glatiramer acetate and other DMTs.1
Prior to the indication expansion, fingolimod was limited for use in those patients with highly active RRMS not responding to an interferon.2
The European Commission approval was based on a favourable review of the long-term efficacy and safety data for fingolimod and comes three years after the initial licence was granted in March 2011.3 Fingolimod is now approved in 80 countries and it is estimated that more than 91,500 patients have been treated with fingolimod in clinical trials and in the post-marketing setting.4
Fingolimod is the only established oral therapy approved by NICE for the treatment of highly active RRMS that is effective across four key measures of MS disease activity - relapses, MRI lesions, brain volume loss and disability progression.5,6
Novartis will work with the relevant funding bodies to ensure that patients who meet these new criteria are able to access fingolimod in the near future.