FDA Approves Oral Treatment Ponesimod for Relapsing Multiple Sclerosis


Nine in 10 patients with multiple sclerosis who received the medication did not have worsening of 3-month disability, and ponesimod showed a numerical benefit in delaying disability progression.

Officials with the FDA have granted approval to ponesimod (Ponvory, Janssen) for the treatment of adults with relapsing multiple sclerosis (MS). According to a press release, clinical trials found that it is superior to teriflunomide in reducing annual relapses and brain lesions.

Ponesimod is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator. It can treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to the press release.

The FDA approval is partially based on a 2-year, head-to-head phase 3 clinical trial in which researchers found that ponesimod demonstrated superior efficacy in significantly reducing annual relapse by 30.5% compared to teriflunomide 14 mg in patients with relapsing MS. Over the study period, 71% of patients treated with ponesimod had no confirmed relapses, compared to 61% in the teriflunomide group.

Ponesimod was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively. These lesions are identified using magnetic resonance imaging technology and are classic measures of MS pathology, which can provide insights into disease activity and disease burden, according to the press release.

The trial results indicate that ponesimod also prevents disability from worsening for most people. Specifically, 9 in 10 patients who received the medication did not have worsening of 3-month disability, and ponesimod showed a numerical benefit in delaying disability progression, according to the study. The difference in rates of disability progression was not statistically significant between the ponesimod and teriflunomide groups.

“MS is a complex disease, and any individual’s response to MS disease-modifying therapy can vary,” said Bruce Bebo, PhD, executive vice president of research at the National MS Society, in the press release. “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.”

Ponesimod leaves the blood within 1 week if treatment needs to be stopped and its effects on the immune system wear off in 1 to 2 weeks for most patients. According to the study authors, this may offer additional flexibility in treatment management if patients need to receive vaccines, address potential infections, or begin family planning. The drug has no known food restrictions and requires no genetic testing or first-dose monitoring for most patients.

“In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide, another oral MS therapy,” said Robert J. Fox, MD, vice-chair for research at the Neurological Institute, Cleveland Clinic, in the press release.

The investigators said ponesimod has a proven safety profile and was generally well-tolerated over multiple clinical studies totaling more than 10 years, with overall adverse event (AE) rates similar to placebo in the phase 2 and teriflunomide in the phase 3 trials. The most common AEs observed were upper respiratory infection, hepatic transaminase elevation, and hypertension. Janssen offers a support program to help patients start on ponesimod and remain adherent.

“Every person with multiple sclerosis is affected differently, given variability in both the underlying disease and emerging symptoms,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development at Johnson & Johnson, in the press release. “Continued innovation in this space is critical, and we’re committed to meeting patients’ evolving health care needs.”


Janssen Announces US FDA Approval of Ponvory (Ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio (teriflunomide) in Reducing Annual Relapses and Brain Lesions [news release]. Janssen Pharmaceuticals; March 19, 2021. https://www.janssen.com/us/news-center/press-releases. Accessed March 19, 2021.

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