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.
Mayzent “has been shown to delay disability progression for people with SPMS with active disease, reducing the decline of both cognitive and physical abilities and thereby helping them to maintain independence for longer,” commented Dr Martin Duddy, clinical director and consultant neurologist at Newcastle upon Tyne Hospitals NHS Foundation Trust.
He continued to say that the MS clinical community “welcomes today’s news, which provides us with a new treatment to support a group of patients who, to-date, have had few options available to help delay the worsening of this often devastating condition.”
There are approximately 110,000 people with MS in the UK, and each year around 5,000 people are newly diagnosed with the condition. It is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.