Novartis granted Russian approval for new MS treatment

Novartis has won its first approval from a healthcare regulator for a new tablet-based multiple sclerosis (MS) treatment.

Russia's Federal Service on Surveillance in Healthcare and Social Development has chosen to approve Novartis' Gilenya 0.5 mg once-daily oral therapy for the treatment of relapsing remitting MS.

The ruling was based on positive data from a phase III clinical trial programme, which demonstrates the drug's efficacy in reducing relapses, disability progression and brain lesions.

Novartis states that the treatment, the first in a new class called sphingosine 1-phosphate receptor modulators, can benefit patients by providing effective therapy in a convenient oral capsule.

The drug has also won a recommendation for approval from the US Food and Drug Administration and will now be reviewed by the European Medicines Agency.

Last week, Novartis reported that its researchers have created a potentially groundbreaking new type of malaria drug, which it hopes can be developed into a once-daily oral therapy.