Novartis on Wednesday said that it got approval from the FDA for Mayzent (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.
Clinically isolated syndrome, or CIS, is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system (CNS) SPMS is a debilitating form of multiple sclerosis (MS) characterized by progressive and irreversible neurological disability. Mayzent is expected to be available in the US in approximately one week. Patients will not require a first dose observation (FDO, cardiac monitoring upon initiation) unless they have certain pre-existing cardiac conditions, the company said in the statement.
Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement from the FDA: “Multiple sclerosis can have a profound impact on a person’s life. We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis.”
“Delaying disability progression is a critical goal of MS treatment, and historically, patients with advancing disease have had very few options to help them,” said Fabrice Chouraqui, President, Novartis Pharmaceuticals Corporation. “We’ve had a longstanding mission to enhance the understanding of MS and help reimagine treatment options, and we’re excited to expand on our legacy with Mayzent for patients with relapsing forms of MS, including SPMS with active disease.”
Bruce Bebo, Executive Vice President, Research, National MS Society, said “We are hopeful this approval will stimulate a conversation between patients and healthcare professionals about disability progression after relapsing remitting MS and its early management.”