Drug Fails to Reduce Disability Risk in Primary-Progressive Multiple Sclerosis

Novartis announced its analysis of fingolimod (Gilenya) in primary-progressive multiple sclerosis (PPMS) resulted in no significant difference from placebo, according to its phase 3 INFORMS study.

The study did not meet its primary endpoint of reducing the risk of 3-month sustained disability progression based on measures of the Expanded Disability Status Scale, upper limb function, and walking speed, according to Novartis.

The manufacturer announced in a press release that its study was based on the knowledge that Gilenya can interact with damage-causing cells in a part of the central nervous system. The study examined whether relapsing forms of MS and PPMS would be similar, but the results ultimately suggested that the 2 have different underlying mechanisms, according to Novartis.

Novartis’s study was the largest clinical trial ever conducted in PPMS, with 970 affected patients aged 25 to 69 years, according to a press release.

"We understand this news is very disappointing for those affected by PPMS and involved in its management. While PPMS is a focus of the MS community, relatively little is known about the disease so finding effective treatments remains a challenge,” said Vasant Narasimhan, global head of development at Novartis Pharmaceuticals, in a press release. “We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease."

PPMS affects about 10% of the 2.3 million patients diagnosed with MS worldwide, according to Novartis. There are currently no approved treatments for PPMS shown to change the course of the disease, the press release stated.