Novartis To Present New Data For MS Drug Gilenya

Novartis is preparing to present new analyses and data for its multiple sclerosis drug Gilenya at the upcoming Joint ACTRIMS-ECTRIMS Meeting in Boston this month. Gilenya, an oral disease-modifying therapy (DMT), has been developed by Novartis for relapsing-remitting multiple sclerosis (RRMS). The drug works by targeting both focal and diffuse central nervous system damage. It prevents inflammation from occurring in the brain and defuses harmful cells inside the CNS. The company recently received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the label expansion of Gilenya in RRMS in the EU.

Treatment of multiple sclerosis centers on NEDA (no evidence of disease activity). This is measured by evidence of relapses, progression of disability, and MRI lesions. Novartis said that its new set of data will help to establish the significance of brain shrinkage or brain volume loss as a fourth key measure of multiple sclerosis. While brain volume loss is normal in aging, MS patients experience earlier and faster brain shrinkage.

Vasant Narasimhan, Global Head of Development at Novartis, said, “The data at ACTRIMS-ECTRIMS will reinforce the role of brain shrinkage and its association with future long-term MS disability progression. Novartis is committed to improving treatment outcomes for people with MS, and we believe that by including brain shrinkage as part of NEDA, clinicians can gain a more complete understanding of disease progression and treatment effects.”

The company also said that additional analyses will demonstrate that patients who received treatment with Gilenya were more likely to achieve NEDA than patients who took placebo. Gilenya-treated patients also had lower rates of brain shrinkage, which were sustained over time. Over 100,000 patients worldwide have been treated with the drug in both clinical studies and post-marketing settings.

Gilenya recently brought in $606 million in profit for Novartis after sales climbed up by nearly 30 percent. The drug’s robust sales as well as turnover in emerging markets helped buoy Novartis in its second quarter financial performance, noted analysts.