Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya (fingolimod) in achieving 'no evidence of disease activity' (NEDA) in people with relapsing-remitting multiple sclerosis (RRMS) across four key disease measures relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures.
NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
"Adopting this more comprehensive definition of NEDA, which includes brain shrinkage, allows for a more detailed assessment of disease activity in patients with MS," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "The data highlight the proven high efficacy of Gilenya, based on this new improved definition, across four key measures of MS."
The loss of physical and cognitive function in MS is driven by two types of damage that result in the loss of neurons and brain tissue distinct inflammatory lesions (referred to as focal damage), and more widespread inflammatory neurodegenerative processes (referred to as diffuse damage). Distinct inflammatory lesions result in the loss of brain tissue and can clinically present as relapses. Widespread inflammatory damage starts early in the disease, often goes unnoticed and is also associated with loss of brain tissue and accumulated loss of function. Redefining NEDA to include four key measures of MS addresses both types of damage, giving physicians a more comprehensive and balanced assessment of MS and treatment effects.
Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. The evolution of MS results in an increasing loss of both physical (e.g. walking) and cognitive (e.g. memory) function. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS, a disease that begins in early adulthood, most often between the ages of 20 and 40.
Gilenya is the only oral disease-modifying therapy (DMT) to impact the course of relapsing-remitting MS (RRMS) with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression.
Gilenya targets both focal and diffuse CNS damage. It prevents cells that cause focal inflammation from reaching the brain (referred to as 'peripheral' action), but also enters the CNS and reduces the diffuse damage by preventing the activation of harmful cells residing in the CNS (referred to as 'central action'). It is important to address both focal and diffuse damage in RRMS to effectively impact disease activity and help preserve an individual's physical (e.g. walking) and cognitive (e.g. memory) function.
Gilenya has been used to treat more than 100,000 patients in a clinical trial and post-marketing setting over ten years and has a well-established safety profile.
Novartis is committed to the research and development of new treatment options to offer the right treatment to the right patient at the right time, to meet patients' needs at every stage of disease with innovative and targeted drugs.
In addition to its ongoing development programme for Gilenya in primary progressive MS (PPMS), paediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP), the Novartis MS portfolio includes Extavia (interferon beta-1b for subcutaneous injection). Investigational compounds include BAF312 (siponimod), currently in phase III clinical development and being developed as the first oral therapy for secondary progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS.