Novartis’ Mayzent granted license by the European Medicines Agency

pharmafile | January 21, 2020 | News story | Manufacturing and Production CNS, European Medicines Agency, NHS, NICE, Novartis 

The European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain adults with secondary progressive multiple sclerosis (SPMS).

Mayzent is a tablet that is taken daily, and is the first oral disease-modifying treatment for patients with an active disease.

The EMA granted the license based on Phase 3 data from the EXPAND trial. The drug was found to delay disease progression, slow the advance of physical symptoms and positively impact cognition in a broad SPMS patient population.

Dr Martin Duddy, Clinical Director and consultant neurologist at Newcastle upon Tyne Hospitals NHS Foundation Trust, said 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.”

He went on to say the 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.”

Novartis now awaits for the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) to make their decisions during the first half of this year.

At the moment there are 110,000 people with multiple sclerosis in the UK and each year around 5,000 people are diagnosed the condition. It’s a chronic disorder of the central nervous system (CNS) that disrupts the normal function of the brain, optic nerves and spinal cord through inflammation and tissue loss.

Conor Kavanagh

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