The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting Mayzent (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosis (SPMS) in the European Union.
Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are generally accepted by the European Commission, which makes the final decisions.
As such, Mayzent — developed and marketed by Novartis — is expected to become the first oral treatment indicated only for people with active SPMS, defined as patients with evident relapses or inflammatory activity in lesions captured on imaging scans.
“Today’s CHMP opinion marks a milestone in supporting people in Europe who are living with active SPMS,” Christoph Thalheim, director of external affairs for the European Multiple Sclerosis Platform, said in a Novartis press release. “This decision brings hope of a possible new and beneficial therapy.”
Mavenclad (cladribine tablets), by the Merck Group, became the first oral therapy for select SPMS patients in the EU. Its 2017 EU approval included all with highly active relapsing MS, including those with relapsing-remitting disease as well as SPMS. The U.S. Food and Drug Administration (FDA) approved Mavenclad for this same patient group — active relapsing MS — in March 2019.
CHMP based its opinion on findings in the Phase 3 EXPAND clinical trial (NCT01665144) in 1,651 patients with SPMS, both active and non-active. According to Novartis, a subgroup analysis showed that 2 mg tablets of Mayzent taken once a day lowered disability progression at three months by 31% in those with active disease, compared with placebo treatment.
At six months, time to confirmed disease progression in active SPMS patients was delayed by 37% overall compared with placebo. The therapy’s use also decreased the annualized relapse rate — the number of confirmed relapses each year — by 46% compared with placebo, Novartis reported.
Furthermore, data presented in September at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), suggested that Mayzent can help patients prolong the time until becoming wheelchair-bound by more than four years.
“For people living with MS, it is extremely important to delay disability progression and preserve cognition, so that they can live independent lives for longer,” said John Tsai, the company’s chief medical officer and head of global drug development. “Mayzent is a testament to the Novartis mission to reimagine medicine for an underserved population such as people living with active SPMS.”
Mayzent works by blocking the activity of two sphingosine-1-phosphate receptors on the surface of immune cells. It prevents immune cells from migrating to the brain and spinal cord, thereby reducing the inflammatory process that promotes MS development and progression.
Should the European Commission support CHMP’s opinion, health authorities in each EU member state will then need to decide whether to bring Mayzent into their respective public health programs, where patients can access the treatment at low or no cost.
“The next step is for UK health bodies to decide whether siponimod should be available on the NHS [National Health Service],” the U.K.’s MS Society said in announcing CHMP’s decision. “We’ll be working hard to make sure that happens as soon as possible. But the process can take some time, and we don’t expect a decision until the middle of 2020.”
In the U.S., Mayzent is FDA-approved for adults with all relapsing MS forms, including clinically isolated syndrome (CIS), RRMS, and active SPMS.
For more information about this therapy, please read MS News Today‘s September interview with Ludwig Kappos, MD, principal investigator of the EXPAND trial.
