Novartis Posts Phase 3 Data For Gilenya In MS

Novartis reported the latest findings from the Phase 3 trial of its drug Gilenya (fingolimod) in primary progressive multiple sclerosis (PPMS), a difficult form of multiple sclerosis.

Gilenya is approved by the U.S. Food and Drug Administration (FDA) as first-line treatment for relapsing forms of MS in adult patients. The drug is approved in the EU for the treatment of highly active relapsing-remitting MS (RRMS). Gilenya is designed to target the focal and diffuse central nervous system (CNS) damage that is behind the loss of function in the disease. Its mechanism of action prevents cells which drive focal inflammation (known as peripheral action) while reducing diffuse damage by hindering the activation of harmful cells in the CNS. Addressing both focal and diffuse damage in relapsing MS is critical to preserving a patient’s physical and cognitive function. Earlier this year, Novartis announced positive results for the drug showing its efficacy across key measures of MS disease activity.

However, the company reported ‘disappointing’ results for the Phase 3 INFORMS study of Gilenya in PPMS. Data showed no significant difference between fingolimod and placebo on a combination of MS disability measures. The drug’s safety profile was reported to be consistent and favorable in relapsing multiple sclerosis.

Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals, said, “We understand this news is very disappointing for those affected by PPMS and involved in its management… 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.”

Primary progressive multiple sclerosis is a distinct form of the disease characterized by a significant lack of acute relapses and fewer active MRI lesions. The disease causes severe irreversible damage to the CNS and a faster, continuous loss of function as the disease progresses. PPMS affects an estimated 10 percent of the 2.3 million patients diagnosed with multiple sclerosis around the world.

There are currently no approved treatments for PPMS, making it a potentially profitable market for the company. According to Bloomberg Businessweek, the drug was forecasted to supposedly bring in $3.2 billion in sales for Novartis.