Novartis reports positive data from Gilenya drug trial

Novartis has announced new clinical trial data that demonstrates the efficacy of its drug Gilenya in the treatment of relapsing multiple sclerosis (RMS).

A new analysis of the phase III FREEDOMS and FREEDOMS II has indicated that previously-treated patients with highly-active RMS who were treated with Gilenya were six times more likely to achieve clear results across four key measures of disease activity compared to placebo over two years.

This status is known as NEDA4 and is achieved when a patient with RMS has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression.

Separate analysis from the phase III TRANSFORMS study also confirmed that after one year of treatment, RMS patients on Gilenya were twice as likely to achieve NEDA4 than when using an established alternative therapy.

Vasant Narasimhan, global head of development at Novartis Pharmaceuticals, said: "NEDA4 is a major step forward in assessing RMS progression, helping physicians to develop effective disease management and treatment strategies for their patients."

These findings were presented at the American Academy of Neurology annual meeting, which is taking place in Washington DC until April 25th.