Janssen Pharma gets USFDA nod for Ponvory to treat relapsing multiple sclerosis
New Jersy: The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (USFDA) approved PONVORY (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), 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 over a decade of cumulative clinical research.
PONVORY also prevented disability from worsening for most people. Nine in 10 PONVORY-treated patients did not have worsening of 3-month disability, and PONVORY showed a numerical benefit in delaying disability progression. The difference in rates of disability progression was not statistically significant between the PONVORY and teriflunomide groups.
"MS is a complex disease, and any individual's response to MS disease-modifying therapy can vary," said Dr. Bruce Bebo, Executive Vice President of Research at the National MS Society. "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."
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.
"In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide, another oral MS therapy. Those results, combined with a favorable side effect profile, make ponesimod a useful treatment option for people with relapsing MS," said Robert J. Fox, M.D., Staff Neurologist, Mellen Center for MS Treatment and Research, Vice-Chair for Research, Neurological Institute, Cleveland Clinic. Dr. Fox has served as a paid consultant to Actelion Pharmaceuticals Ltd and Janssen as a member of the ponesimod Advisory Board.
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).
"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," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "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."
Janssen CarePath offers a comprehensive support program that helps 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.