Phase IIIb ASSESS study of Gilenya meets primary endpoint against Copaxone in MS.- Novartis.

Novartis announced 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. 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). 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. 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.

Comment: 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.