Gilenya and Primary Progressive Multiple Sclerosis-Novartis

Novartis announced that the Phase III INFORMS study in Primary Progressive Multiple Sclerosis (PPMS) did not show a significant difference between Gilenya (fingolimod) and placebo on a combination of disability measures. The safety results were consistent with the well-characterized safety profile of fingolimod in relapsing MS (RMS).

PPMS is a disorder of the central nervous system (CNS) which affects approximately 10% of the 2.3 million patients diagnosed with MS worldwide. 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. The severe irreversible damage to the CNS in PPMS is thought to be caused by different pathways leading to loss of nerve cells and a more rapid, continuous loss of function over time which profoundly impacts patients' lives. Additionally, the disease is typically diagnosed later than other types of MS, when significant damage to the CNS has already occurred. Despite considerable 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.