Novartis AG said full results from a phase 3 study of siponimod showed that the drug significantly improved outcomes in patients with a certain type of multiple sclerosis.
Data from the trial, called Expand, showed siponimod cut the risk of disability progression at three months by 21% in patients with secondary progressive multiple sclerosis, or SPMS, compared to placebo. At six months, the reduction in disability progression risk was 26%.
Additionally, the drug slowed the rates of brain volume loss and increase in certain brain lesions by 23% and about 80%, respectively. The medicine, called BAF312, also lowered the annualized relapse rate by 55%.
Siponimod's safety profile was consistent with previous reports.
Novartis plans to file for regulatory approval of siponimod for SPMS with the U.S. Food and Drug Administration in early 2018. The Swiss pharmaceutical giant also plans to file with the European Medicines Agency in the third quarter of 2018, pending the outcome of a consultation with the regulator. If approved, siponimod would be the first SPMS treatment of its kind, according to Novartis.
The expanded study included 1,651 people with SPMS from 31 countries.
MS is characterized by nerve damage in the brain and the spine, leading to loss of physical and cognitive function. The disorder affects about 2.3 million people worldwide.