Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment.
Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, according to a news release.
Janssen’s touts its drug as capable of offering MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy. It’s also proven to have a strong safety profile, the company said.
In a two-year, head-to-head Phase 3 clinical trial, Ponvory (20mg) proved to have superior efficacy in significantly reducing annual relapses by 30.5% when compared to teriflunomide (Aubagio) (14mg) in patients with relapsing MS. In total, 71% of Ponvory patients had no confirmed relapses, compared to 61% in the teriflunomide group.
Additionally, Ponvory slightly edged teriflunomide in reducing the number of new gadolinium-enhancing T1 lesions and the number of new or enlarging T2 lesions (59% and 56%, respectively). Ponvory prevented disability from worsening in nine of 10 patients at three months, too.
Ponvory leaves the blood within one week if treatment needs to be stopped, Janssen said, while effects on the immune system wear off in one to two weeks for most patients. That can offer flexibility in treatment management for patients who need to receive vaccines, address potential infections or begin family planning. There are no known food restrictions and there is no required genetic testing or first-dose monitoring for most patients taking Ponvory.
“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,” Janssen R&D global head Dr. Mathai Mammen said in the release. “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.”