Novartis wants new treatment goal in MS

Novartis is calling for brain shrinkage to be added to existing treatment goals in multiple sclerosis (MS).

New analyses, to be presented at the Joint ACTRIMS-ECTRIMS Meeting in the US next week, will reinforce the clinical relevance of brain shrinkage (brain volume loss) and highlight the benefit of including it as a fourth key measure of MS.

Currently, the goal of MS treatment is to have ‘no evidence of disease activity’, or NEDA, which is defined as no evidence of relapses, MRI lesions and disability progression. In addition, other analyses will show that patients treated with Gilenya (fingolimod) are more likely to achieve NEDA based on assessment of these four key measures, including MS-related brain shrinkage, than those on placebo.

Everyone’s brain shrinks as they age, but people with MS experience brain shrinkage up to three-to-five times faster. Brain shrinkage begins early in MS, even before symptoms occur, and is associated with a loss of physical and cognitive function.

New Gilenya analyses will show how brain shrinkage is associated with future long-term disability progression in patients with MS and that patients with relapsing MS treated with Gilenya had lower rates of brain shrinkage that, importantly, were sustained over time. The findings will also provide further evidence of the high efficacy of Gilenya on MS disease activity across four key measures.

Vasant Narasimhan, global head of development at Novartis Pharmaceuticals, said “We believe that by including brain shrinkage as part of NEDA, clinicians can gain a more complete understanding of disease progression and treatment effects.”

Gilenya is the only oral disease-modifying therapy to impact the course of relapsing-remitting MS (RRMS) with high efficacy across relapses, MRI lesions, brain shrinkage and disability progression. It targets both focal and diffuse central nervous system (CNS) damage, which is important to effectively impact disease activity and help preserve physical and cognitive function.

Gilenya is also being tested as a treatment for motor neurone disease, which has been the subject of the hugely successful viral social media campaign known as the ALS Ice Bucket Challenge.

In addition to its ongoing development programme for Gilenya in primary progressive MS (PPMS), paediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP), Novartis also has Extavia (interferon beta-1b for subcutaneous injection). It is also developing investigational compound BAF312 (siponimod), currently in phase III clinical development as the first oral therapy for secondary progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS.

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