Wider use of Novartis’ Gilenya approved in Europe

The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Swiss drug major Novartis’ (NOVN: VX) blockbuster drug Gilenya (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis (RRMS).

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 (Teva’s Copaxone) and other DMTs.

Prior to the indication expansion, fingolimod, which generated sales of nearly $2 billion last year, was limited for use in those patients with highly active RRMS not responding to an interferon.