EU clears Novartis oral multiple sclerosis drug Gilenya

Swiss pharma major Novartis (NOVN: VX) this morning announced that the European Commission has granted approval its Gilenya (fingolimod) 0.5mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in people with rapidly evolving severe RRMS.

Last year, the US Food and Drug Administration approved Gilenya as first-line therapy for use in all patients with relapsing-remitting MS (The Pharma Letter September 22, 2010). At that time, analysts at Nomura raised their global revenue forecast for the drug from $2 billion to $3.5 billion, calling the US approval as the dawn of a new “Gilleennium” for MS. The European decision excludes some patients, giving the drug a narrower part of the European market than it has in the USA, where Gilenya costs $48,000 annually.

Prospects for oral MS drugs