Novartis to get priority review for multiple sclerosis drug

Novartis is to be granted a priority review by the Food and Drug Administration (FDA) for its promising new multiple sclerosis treatment Gilenia.

The regulator is cutting its standard ten-month review period to six months, as the orally-administered treatment has been deemed to offer significant potential advances over current options.

Its safety and efficacy has been supported by evidence from multiple phase III clinical trials, which demonstrated its usefulness in reducing relapses, disability progression and brain lesions.

If ratified by the FDA, it will become the first approved oral therapy for the treatment of multiple sclerosis.

Dr Trevor Mundel, global head of development at Novartis Pharma, said: “We welcome the decision granting priority review to Gilenia, which underscores the potential benefits of this medicine to patients.”

This comes after the FDA earlier this week also granted a priority review to Tasigna, Novartis’ treatment for early-stage chronic myeloid leukaemia.