Novartis’ groundbreaking MS drug receives CHMP backing

Novartis has received a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP) for the approval of a potentially groundbreaking new multiple sclerosis (MS) drug.

The European Medicines Agency committee has recommended that the regulator grants marketing authorisation to Novartis' Gilenya as a disease-modifying therapy among patients with highly active relapsing-remitting MS who have proven unresponsive to beta interferon treatment.

Its decision was based upon positive data from a large-scale clinical trial programme and acknowledges the efficacy of Gilenya, which would become Europe's first oral MS treatment if approved.

The European Commission will now come to a final licensing decision based on the CHMP's guidance, with a final ruling to be issued in around three months.

David Epstein, division head of Novartis Pharmaceuticals, said: "Novartis is committed to providing innovative medicines like Gilenya to patients with MS and we look forward to working with countries across Europe towards this goal."

Last week, Novartis announced the UK availability of its chronic myeloid leukaemia drug Tasigna among a wider patient demographic, following its approval as a treatment for adults with newly-diagnosed chronic phase Philadelphia chromosome-positive forms of the illness.