The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). The treatment is taken as a 20 mg tablet, once daily, with or without food.
“MS is a complex disease, and any individual’s response to MS disease-modifying therapy can vary. 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,” Bruce Bebo, PhD, executive vice president of research at the National MS Society, said in a press release.
Ponvory, developed by Janssen, works by modulating sphingosine-1-phosphate (S1P) signaling. This is believed to “trap” immune cells in lymph nodes, so they cannot get into the nervous system and cause damaging inflammation.
The FDA’s approval of Ponvory was supported by results from the pivotal Phase 3 OPTIMUM clinical trial (NCT02425644). In this trial, the efficacy and safety of Ponvory were compared to those of Aubagio (teriflunomide), an approved first-line therapy for MS marketed by Sanofi.
Like Ponvory, Aubagio is an oral therapy that works by reducing the activity of the immune system, though the exact biological mechanisms of the two therapies are different.
OPTIMUM enrolled 1,133 people with RRMS or active SPMS, who were assigned randomly to receive either Ponvory (20 mg) or Aubagio (14 mg) daily for 108 weeks (about two years).
Top-line results from the trial demonstrated that Ponvory significantly reduced the frequency of relapses by 30.5%, compared with Aubagio; the average annual relapse rate with Ponvory was 0.202 versus 0.290 with Aubagio.
Over the two-year study period, 71% of Ponvory-treated participants had no relapses, as compared to 61% of Aubagio-treated participants. Ponvory also outperformed Aubagio at preventing brain lesions — as measured using magnetic resonance imaging (MRI) technology — and easing fatigue.
Although rates of disability progression were not significantly different between the two therapies, nine in 10 Ponvory-treated participants had no disability worsening after three months, according to Janssen.
“In the pivotal study, ponesimod [Ponvory] demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide [Aubagio], another oral MS therapy,” said Robert Fox, MD, a neurologist at the Cleveland Clinic in Ohio and a member of Janssen’s Ponvory Advisory Board.
“Those results, combined with a favorable side effect profile, make ponesimod a useful treatment option for people with relapsing MS,” Fox added.
The safety of Ponvory in OPTIMUM was generally consistent with that of other S1P modulators. Common side effects of the medication include upper respiratory tract infections, elevated blood pressure, and abnormally high levels of certain liver enzymes.
Because starting treatment with Ponvory can cause a decrease in heart rate, people with certain heart conditions need to be monitored when taking their first dose. People without these pre-existing heart conditions do not require first-dose monitoring, and Ponvory treatment does not require genetic testing.
If treatment with Ponvory needs to be stopped, the therapy’s effects on the immune system wear off within a week or two of ceasing treatment, according to Janssen. This may offer additional flexibility, for example, if patients need to receive vaccines or address potential infections.
“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, MD, PhD, global head of Janssen Research and Development, Johnson & Johnson.
Janssen offers a program called Janssen CarePath to provide patients and healthcare providers with information about Ponvory and other medications.
This includes information about treatment support, insurance coverage, potential out-of-pocket costs, and ways to make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible. There also are programs to provide patients with one-on-one support.
Janssen submitted an application last year seeking the approval of Ponvory in the European Union; the application is under review.
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