Novartis Receives CHMP Recommendation For Gilenya EU Label Expansion

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation to expand the EU label for Gilenya (fingolimod), an approved drug in the EU for adult patients with relapsing remitting multiple sclerosis (RRMS). The label expansion for Gilenya will include adult patients who have not responded to at least one disease-modifying therapy (DMT), including newly-approved oral DMTs.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said, “We are very pleased that the CHMP has recognized the favorable benefit-risk profile of Gilenya and made a recommendation to broaden its label to allow patients who have failed on other disease-modifying therapies to be switched to Gilenya treatment. Additionally, the new analyses at AAN confirm Gilenya's robust efficacy across four key measures of MS disease activity, which is important to give patients as much time free of functional impairment.”

Multiple sclerosis is a chronic disorder of the central nervous system characterized by an increasing loss of both physical and cognitive functions. The disease targets the normal functions of the brain, optic nerve, and spinal cord. Up to 2.3 million people around the world are affected by MS.

Gilenya (fingolimod) is a once-daily oral disease modifying therapy approved in both the U.S. and EU for relapsing forms of MS. The drug reduces both the distinct inflammatory lesions and the ongoing, underlying damage in the brain.

The company also presented pooled analyses from the FREEDOMS and FREEDOMS II trials demonstrating efficacy in patients with high disease activity previously treated in the past year. The data shows that Gilenya was effective across four key measures of multiple sclerosis: relapse rates, MRI lesions, brain volume loss, and disability progression. Compared to placebo, the drug reduced relapses by 48 percent, MRI lesions by 69 percent, brain volume loss by 46 percent, and disability progression by 45 percent.

The data were presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania.