Novartis AG said the European Commission approved its drug Mayzent for treating certain patients with multiple sclerosis, an autoimmune disorder.
The Swiss drugmaker said the regulator approved the oral treatment for adult patients with secondary progressive multiple sclerosis, or MS, with active disease evidenced by relapses or imaging features of inflammatory activity.
MS is characterized by nerve damage in the brain and the spine, leading to the loss of physical and cognitive function. The secondary progressive type of the disease is characterized by gradual and irreversible worsening of disability in patients. MS affects about 2.3 million people globally.
The approval is based on data from a phase 3 study of the therapy, called Expand, which showed that Mayzent, or siponimod, cut the risk of disability progression at three months by 21% in patients with secondary progressive MS compared to placebo.
The European Commission's nod came after the European Medicine Agency's Committee for Medicinal Products for Human Use recommended Mayzent's approval in November 2019.
Mayzent was also approved in the U.S. on March 2019 in patients with relapsing forms of multiple sclerosis, including secondary progressive MS, with active disease, relapsing-remitting multiple sclerosis and clinically isolated syndrome.