FDA Approves Treatment for Relapsing Forms of MS
- By Laurie Watanabe
- Apr 07, 2021
The U.S. Food & Drug Administration (FDA) has approved a new drug treatment for several forms of multiple sclerosis (MS) in adults.
The drug, called Ponvory, is a 20-mg tablet taken orally once a day, according to a March news announcement from Multiple Sclerosis News Today. The drug is produced by Janssen.
The FDA approval covers the use of Ponvory for patients with Clinically Isolated Syndrome, Relapsing-Remitting MS, and Active Secondary Progressive MS.
A Janssen news announcement said the new medication “offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.”
Janssen added that in a two-year, head-to-head Phase 3 clinical trial, Ponvory “demonstrated superior efficacy in significantly reducing annual relapses by 30.5 percent compared to teriflunomide (Aubagio) 14 mg in patients with relapsing MS. Over the study period, 71 percent of patients treated with Ponvory had no confirmed relapses, compared to 61 percent in the teriflunomide group.”
Because Ponvory leaves a patient’s blood within one week of treatment stoppage, with immune system effects wearing off in one to two weeks, it could be possible for patients taking the drug to pause treatment if required to receive a vaccine or seek treatment for an infection.
Bruce Bebo, Executive VP of Research, National MS Society, said of the news, “MS is a complex disease, and any individual’s response to MS disease-modifying therapy can vary. It’s so important that people living with MS have access to effective treatment options. We are pleased that there is a new therapy approved for relapsing MS.”
Laurie Watanabe is the editor of Mobility Management. She can be reached at email@example.com.