Novartis Announces Results From Phase IIIb ASSESS Study

(RTTNews) - Novartis (NVS) announced results from the Phase IIIb ASSESS study, which evaluated the efficacy and safety of oral, once daily Gilenya or fingolimod 0.5mg and 0.25mg versus once daily subcutaneous injections of Copaxone or glatiramer acetate 20mg in patients with relapsing remitting multiple sclerosis or RRMS.

The data show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate or 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, p= 0.0138).

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.

Gilenya 0.5mg is a 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. 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. Gilenya 0.25mg is not approved for adults with RRMS.

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