A similar request to the U.S. Food and Drug Administration (FDA) is expected “within this month,” Luc Truyen, MD, PhD, global head of development and external affairs for neuroscience at Janssen (part of Johnson & Johnson), said in an interview with Multiple Sclerosis News Today.
Phase 3 trial data showing ponesimod — whose brand name is “still under discussion” — lowered relapse rates and eased fatigue more effectively than Aubagio (teriflunomide), an established and oral MS therapy, support the EMA application.
Results also supported a good safety profile, and a rapid reversibility that could be useful should treatment need to quickly cease for family planning or other life events.
“First and foremost,” what best distinguished ponesimod from Aubagio “is a high degree of efficacy — again, clear superiority over a widely used oral,” Truyen said.
Then, there’s “rapid reversibility,” he added. “Within one week, lymphocyte counts start to return to normal, which is relevant for many situations, vaccinations that are coming, pregnancy desire.”
Efficacy over an approved oral therapy
The Phase 3 OPTIMUM (NCT02425644) clinical trial tested ponesimod in 1,133 people with relapsing forms of MS — mostly relapsing-remitting MS (RRMS), followed by active secondary progressive MS (SPMS, about 15% of patients). Participants were randomized to either ponesimod tablets at 20 mg daily or Aubagio tablets at 14 mg daily for 108 weeks.
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