Ponvory Approved in EU for Active Relapsing Forms of MS
The approval, which follows a recommendation from the Committee for Medicinal Products for Human Use in March, covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
A similar approval was also recently granted to Ponvory in the U.S. The treatment is taken as a 20 mg tablet, once daily, with or without food.
“I welcome the European Commission’s approval of ponesimod as an additional treatment option for those living with relapsing multiple sclerosis — it will provide patients with additional choice when making decisions about their treatment,” Gavin Giovannoni, PhD, professor of neurology at Queen Mary University of London, said in a press release.
“Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” he added.
Ponvory, developed by Janssen, is a modulator of the sphingosine-1-phosphate (S1P) signaling that traps immune cells in lymph nodes and prevents them from causing inflammation in the nervous system.
The approvals were based on data from the OPTIMUM Phase 3 trial (NCT02425644), which compared the safety and efficacy of Ponvory to those of Aubagio (teriflunomide), another approved first-line MS therapy. Both medicines lessen the immune response that aggravates MS but act in different ways.
OPTIMUM included 1,133 adults with RRMS or active SPMS who were randomly assigned to receive oral Ponvory (20 mg) or Aubagio (14 mg) once daily for approximately two years.
Over that time, Ponvory reduced participants’ annual number of relapses by 30.5% compared with Aubagio, lowered the number of new inflammatory brain lesions seen via magnetic resonance imaging by 56%, and showed a statistically significant improvement in combined unique active lesions.
Treatment-related adverse side effects occurred at similar rates for each therapy. Most were mild to moderate and did not cause participants to discontinue treatment.
The most commonly reported adverse effects in either group were elevated liver enzymes, indicating liver damage (19.5% in the Ponvory group vs. 9.4% in the Aubagio group), a cold (19.3% vs. 16.8%), headache (11.5% vs. 12.7%), upper respiratory tract infection (10.6% vs. 10.4%), and alopecia or hair loss (3.2% vs. 12.7%).
Overall, Ponvory’s safety profile is consistent with that of other S1P receptor modulators, although direct comparisons are unavailable.
“The OPTIMUM study is the first Phase 3 study establishing superiority versus another disease modifying treatment for relapsing multiple sclerosis, with ponesimod showing significant reductions in annual relapse rates versus teriflunomide, an active comparator and widely-used first-line oral treatment,” said Catherine Taylor, MD, a vice president at Johnson & Johnson Middle East.
“The approval of ponesimod by the European Commission is a positive step for people living with relapsing multiple sclerosis, as we work to provide them with an additional treatment option to manage and control their condition,” Taylor added.