Ponvory receives FDA approval for relapsing MS

The FDA has approved ponesimod, a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator, to treat adults with relapsing forms of MS, Janssen announced in a press release.

The approval — which applies to adults with clinically isolated syndrome, relapsing-remitting MS and active secondary disease — came after the head-to-head, prospective, multicenter, randomized, double-blind phase 3 OPTIMUM trial that compared 20 mg ponesimod (Ponvory, Janssen) with 14 mg teriflunomide, according to the press release. The study’s primary endpoint was the annualized relapse rate from baseline through the end of the 2-year study period; other endpoints of interest included the number of new gadolinium-enhancing (GdE) T1 lesions, the number of new or enlarging T2 lesions and time to 3-month and 6-month disability progression, the release said.

“In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide, another oral MS therapy,” Robert J. Fox, MD, staff neurologist at the Mellen Center for MS Treatment and Research and vice chair for research at the Cleveland Clinic’s Neurological Institute, said in the release. “Those results, combined with a favorable side effect profile, make ponesimod a useful treatment option for people with relapsing MS.”

Among the 1,133 adults who participated, 71% in the ponesimod group had no confirmed relapses vs. 61% in the teriflunomide group, according to data cited in the release. The ponesimod group also experienced a 59% reduction in the number of new GdE T1 lesions and a 56% reduction in the number of new or enlarging T2 lesions.

Although the release noted that there was no statistically significant difference in the rates of 3-month and 6-month disability progression, it also said ponesimod “showed a numerical benefit in delaying disability progression,” with 9 in 10 patients having no worsening of 3-month disability.

Ponesimod was “generally-well tolerated” in over 10 years of clinical studies, according to the release. The most common adverse events in the phase 3 trial were upper respiratory infection, hepatic transaminase elevation and hypertension.