After Head-to-Head Study with Sanofi Drug, FDA Approves Janssen’s Relapsing Multiple Sclerosis Drug

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The U.S. Food and Drug Administration (FDA) approved a new treatment for relapsing forms of multiple sclerosis. This morning, Janssen announced Ponvory (ponesimod) has been greenlit as the only oral disease-modifying therapy studied against an established oral comparator for this indication.

Ponvory, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, was specifically approved to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In its announcement, Janssen, a division of Johnson & Johnson, said Ponvory provides MS patients “superior efficacy in reducing annualized relapse rates and new brain lesions.” Ponvory is a member of a class of drugs believed to inhibit S1P activity and reduce the number of circulating lymphocytes by trapping them in the lymph nodes. Limiting the ability of inflammatory cells available to cross into the central nervous system, it will protect myelin, the protective sheath that insulates nerve cells and is damaged in patients with multiple sclerosis.

Approval of Ponvory was based on a two-year, head-to-head Phase III clinical trial that pitted Janssen’s therapy against Sanofi’s established oral MS drug, Aubagio. Data from the OPTIMUM trial showed Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to Aubagio (teriflunomide) 14 mg in patients with relapsing MS. Trial data also showed treatment with Ponvory prevented a worsening disability in most patients. Nine of 10 patients treated with Ponvory in the study did not have worsening of three-month disability and treatment showed a numerical benefit in delaying disability progression, Janssen said. However, the company noted that the difference in rates of disability progression was not statistically significant between Ponvory and Aubagio.

Sanofi’s Aubagio was first approved by the U.S. Food and Drug Administration in 2012 as a treatment for multiple sclerosis, a chronic autoimmune inflammatory disease of the central nervous system that affects more than 2.3 million people worldwide. The main subtype of multiple sclerosis is the relapsing forms of MS, which represents approximately 85% of MS patients. Relapses are defined as new, worsening or recurrent neurological symptoms that last for more than 24 hours with the absence of fever or infections.

“Every person with multiple sclerosis is affected differently, given variability in both the underlying disease and emerging symptoms. Continued innovation in this space is critical, and we're committed to meeting patients' evolving healthcare needs," Mathai Mammen, Global Head of Janssen Research & Development said in a statement. “We are proud to offer Ponvory as a valuable new option for people with MS that may help them gain better control of their disease.”

If treatment needs to be stopped, Ponvory leaves the blood within one week, with effects on the immune system wearing off in one to two weeks for most patients, Janssen said. This may offer additional flexibility in treatment management if patients need to receive vaccines, address potential infections, or begin family planning.

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