New clearances follow swiftly behind CHMP’s recommendation that Gilenya be sanctioned by the EC.
The Swiss and Australian regulatory authorities have both cleared Novartis’ Gilenya® (fingolimod) as first-line disease-modifying therapy for patients with relapsing-remitting multiple sclerosis (RRMS). Novartis announced the approvals just three days after EMA’s Committee for Medicinal Products for Human Use separately recommended approval of the drug within the EU. The sphingosine 1-phosphate receptor (S1PR) modulator is already approved in the U.S. and Russia.
Gilenya’s approval in Switzerland and Australia is based on data from what Novartis claims is the largest clinical trial program conducted in MS to date. Trial data showed that treatment with Gilenya reduced relapses by 52% after a year when compared with therapy using interferon beta-1a. A two-year study also showed Gilenya led to a 54% reduction in relapse rate when compared with placebo. Patients in this trial also demonstrated a 30% lower risk of disability progression after three months, and a 37% lower risk of disability progression after six months.
Novartis has developed Gilenya under license from Mitsubishi Tanabe Pharma.