Novartis AG said Gilenya, in a late-stage study, worked better than Teva Pharmaceutical Industries Ltd's Copaxone in reducing the recurrence of a common form of multiple sclerosis.
Multiple sclerosis affects the central nervous system by disrupting the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.
Both Gilenya and Copaxone are approved to treat relapsing remitting multiple sclerosis, or RRMS, which is characterized by an attack of new symptoms or relapses followed by complete recovery, called remission.
Novartis' phase 3b study of Gilenya, named Assess, compared 0.5-milligram and 0.25-milligram doses of Gilenya tablet with a 20-milligram dose of Copaxone injection among 1,064 patients with RRMS.
The study met its main goal, with Gilenya 0.5mg resulting in a 40.7% relative reduction in the rate of relapses among patients over one year versus Copaxone. However, the 0.25mg dose of Gilenya failed to show a statistically significant improvement in reducing relapses compared to Copaxone.
Switzerland-based Novartis said the safety of both the Gilenya doses was similar to their known safety profile, with the Copaxone arm resulting in higher discontinuations due to side effects and unsatisfactory treatment results.
The study was launched as part of a post-approval commitment with the U.S. Food and Drug Administration and makes Gilenya 0.5mg the only multiple sclerosis disease-modifying therapy to show better results than Copaxone in treating RRMS in a head-to-head comparison.
Disease-modifying drugs work with different parts of the immune system to reduce the inflammation caused by MS, helping reduce the number and severity of relapses.
Gilenya 0.25 milligram is not indicated to treat adults with RRMS, but Gilenya 0.5mg is approved in the U.S. for children and adolescents aged 10 years and older with RRMS.
Copaxone, also called glatiramer acetate, comes in both 20-milligram and 40-milligram doses, with the latter accounting for the majority of the drug's sales in the U.S.
Novartis' generic unit Sandoz and Mylan NV already sell a generic version of both Copaxone doses in the U.S.