Novartis Announces EC Approval of MS Drug

Novartis announced on Jan. 20, 2020 that the European Commission (EC) approved Mayzent (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. The drug is currently the only oral therapy designated for the condition.

The approval is based on a successful placebo-controlled trial that compared the efficacy and safety of the drug versus placebo in a range of SPMS patients, according to a company press release. The results of the trial showed the three‑month and six‑month confirmed disability progression was reduced by 31% compared to placebo and by 37% compared to placebo.

“We are delighted by the news that there is now a treatment available for people in Europe living with active SPMS to potentially delay the progression of this debilitating disease,” said Pedro Carrascal, president of the European MS Platform, in the press release. “This treatment brings hope for improved care and quality of life to patients who have long been underserved.”

“As the only indicated oral therapy proven for people living with SPMS with active disease, we are pleased that the European approval of Mayzent will help change the conversation about progressing MS and expand possibilities for patients and their caregivers,” added Max Bricchi, global head, Neuroscience Franchise, Novartis, in the press release. “Delaying progression is hugely important for people living with MS who want to maintain independence longer and today’s decision gives them a chance to achieve this goal. We are dedicated in our mission to reimagine medicine and enable brighter futures for people with severe progressive diseases like MS.”

Prior to the EC approval, Mayzent was approved in March 2019 by FDA for the treatment of relapsing forms of multiple sclerosis, clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults. It was also approved by the Australian Therapeutic Goods Administration in November 2019 for the treatment of adult patients with SPMS.

Source: Novartis