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Fingolimod trial for PPMS does not meet primary endpoint

12/2/2014

Novartis’ Phase III INFORMS study in primary progressive multiple sclerosis did not show a significant difference between fingolimod and placebo on a combination of disability measures in clinical trials. The safety results, however, were consistent with the well-characterized safety profile of fingolimod in relapsing MS.

PPMS is a distinct disease form, different from relapsing MS in terms of its basic disease process, near-absence of acute relapses and fewer active MRI lesions. Despite research and academic focus, there are currently no approved treatments that have been shown to change the course of this debilitating disease and management focuses mainly on the treatment of symptoms.

The INFORMS study was based on the knowledge that fingolimod enters the central nervous system and can interact with damage-causing cells residing in the CNS. As opposed to the consistently strong efficacy seen in relapsing MS, the results of the INFORMS study seem to suggest that PPMS and relapsing forms of MS have different underlying mechanisms.

“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. We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. “Gilenya (fingolimod) revolutionized the treatment of relapsing MS as the first oral disease-modifying therapy. We remain strongly committed to continuing to research new treatment options for patients with MS and other neurological conditions.”



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