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 sclerosis

Novartis International AG / 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 sclerosis . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• 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

Basel, October 10, 2018 - 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."