Novartis: Superior efficacy of Gilenya over Copaxone in MS

• Topline findings from ASSESS show adult relapsing remitting multiple sclerosis (RRMS) patients taking Gilenya (fingolimod) 0.5mg experienced significantly fewer relapses than patients on Copaxone (glatiramer acetate) 20mg
• Gilenya 0.5mg is the first and only disease modifying therapy to show superiority in reducing relapses vs Copaxone in a controlled, head-to-head trial
• Treatment discontinuations were overall more common in the Copaxone group due to adverse events and unsatisfactory therapeutic effects

Novartis announced today topline results from the Phase IIIb ASSESS study, which evaluated the efficacy and safety of oral, once daily Gilenya (fingolimod) 0.5mg and 0.25mg versus once daily subcutaneous injections of Copaxone (glatiramer acetate) 20mg in patients with relapsing remitting multiple sclerosis (RRMS). The data show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate (ARR) compared to Copaxone[1]. Treatment with Gilenya 0.5mg resulted in a 40.7% relative reduction in the rate of relapses over a period of one year, compared to Copaxone (ARR estimates of 0.153 vs. 0.258, respectively, p= 0.0138)[1]. Further initial findings showed adults taking Gilenya 0.25mg achieved a numerical risk reduction in relapses compared to the comparator, but did not reach statistical significance. The safety of Gilenya observed in ASSESS across both doses was consistent with the known safety profile of the drug, with overall more discontinuations due to adverse events and unsatisfactory treatment effects reported in the Copaxone group[1].

“ASSESS is the first controlled head-to-head study of a MS disease modifying therapy versus Copaxone to show superior efficacy in reducing relapses, a key measure of disease activity and a significant burden for patients,” said Bruce Cree, MD, PhD, MAS, George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California San Francisco, and ASSESS Principal Study Investigator. “Head-to-head trials, such as ASSESS, are extremely important to help clinicians better understand the relative efficacy and safety of MS therapies, thereby making better-informed treatment decisions.”

“Gilenya reimagined MS care as the first oral treatment and is a testament to Novartis’ quest to stop MS,” said Danny Bar-Zohar, Global Head of Neuroscience Development, Novartis Pharmaceuticals. “The ASSESS data add to the robust body of evidence which show that Gilenya is a highly efficacious, cornerstone therapy in relapsing MS.”

Gilenya 0.5mg is a leading oral disease-modifying therapy, that has demonstrated high efficacy across multiple measures of disease activity in patients 10 years of age and through to adulthood. To date, Gilenya 0.5mg has been used to treat more than 255,000 patients worldwide[1]. Long-term experience has shown Gilenya treatment to be convenient for people to incorporate into everyday life, leading to high treatment satisfaction, long-term persistence, and ultimately, improved long-term outcomes[2],[3]. Gilenya 0.25mg is not approved for adults with RRMS.

Novartis will complete full analyses of the ASSESS data and intends to submit the full results to upcoming medical meetings and for peer-reviewed publication.

https://globenewswire.com/news-release/2018/10/10/1619621/0/en/Novartis-announces-new-data-from-the-first-direct-head-to-head-trial-to-demonstrate-superior-efficacy-of-Gilenya-over-Copaxone-in-patients-with-relapsing-remitting-multiple-scleros.html