Europe – EMA licenses Mayzent for MS

Novartis has revealed that the European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain adult patients with secondary progressive multiple sclerosis (SPMS).

The treatment, a once-daily tablet, is the first and only oral disease-modifying therapy for patients with active disease evidenced by relapses or imaging features of inflammatory activity.

The company says that the license is based on Phase III EXPAND trial data, after Mayzent was found to delay disease progression, slow the advance of physical symptoms and positively impact cognition in a broad SPMS patient population.

On the news, the company now expects initial decisions from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) in the first half of 2020…