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 - Seite 2

"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.

About the ASSESS Study
The ASSESS study (NCT01633112) is a Phase IIIb randomized, rater- and dose-blinded study to compare the safety and efficacy of Gilenya (fingolimod) 0.25mg and 0.5mg administered orally once-daily, with Copaxone (glatiramer acetate) 20mg administered via subcutaneous injections once-daily, in patients with RRMS over the course of one year.

Novartis initiated the ASSESS study in 2012 as part of a post-approval commitment to the US FDA. In agreement with the FDA, a total of 1,064 patients were enrolled into ASSESS, with 352, 370 and 342 patients randomized in Gilenya 0.5mg, Gilenya 0.25mg and Copaxone 20mg arms respectively.

About Multiple Sclerosis
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[4]. In adults, there are three main types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS)[5]. Approximately 85% of people with MS have relapsing-remitting MS, where the immune system attacks healthy tissue[6]. In children, RRMS account for nearly all cases (approximately 98%)[7].