FDA approves Ponvory an Oral Treatment for relapsing MS

March 19, 2021
The U.S. Food and Drug Administration approved Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator, to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Ponvory offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by more than a decade of cumulative clinical research.

The FDA approval of the treatment by the Janssen Pharmaceutical Companies of Johnson and Johnson is based, in part, on a two-year, head-to-head Phase 3 clinical trial in which Ponvory 20 mg showed superior effectiveness in significantly reducing annual relapses by 30.5 percent compared to Aubagio (teriflunomide) 14 mg in patients with relapsing MS. During the study period, 71 percent of patients treated with Ponvory had no confirmed relapses, compared to 61 percent in the teriflunomide group. 

Ponvory was also superior to teriflunomide in reducing the number of new gadolinium-enhancing T1 lesions and the number of new or enlarging T2 lesions by 59 percent and 56 percent, respectively. GdE T1 lesions and T2 lesions are identified using magnetic resonance imaging technology and are recognized as classic measures of MS pathology that can provide insights into disease activity and disease burden, respectively. Ponvory also prevented disability from worsening for most people. Nine in 10 Ponvory-treated patients did not have worsening of three-month disability, and Ponvory showed a numerical benefit in delaying disability progression.

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. This may offer additional flexibility in treatment management if patients need to receive vaccines, address potential infections, or begin family planning. Ponvory has no known food restrictions and requires no genetic testing or first-dose monitoring for most patients.

Ponvory has a proven safety profile and was generally well-tolerated over multiple clinical studies totaling more than 10 years, with overall adverse event rates similar to placebo in the Phase 2 and teriflunomide in the Phase 3 trials. The most common adverse events observed in the Phase 3 trial in Ponvory-treated patients were upper respiratory infection, hepatic transaminase elevation (abnormal liver tests) and hypertension (high blood pressure).

Janssen CarePath offers a comprehensive support program to help patients get started on Ponvory and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible. For patients who are prescribed Ponvory, the Wellness Companion Program by Janssen CarePath provides patients with one-on-one education to help them get started and continue treatment.

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