The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.
Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis
The FDA has greenlit Pfizer’s ulcerative colitis drug etrasimod, marketed as Velsipity, based on Phase III results published in The Lancet, the company announced Friday.
Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, examined the safety and efficacy of a 2-mg daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy.
Both studies “achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” Pfizer said in Friday’s announcement. In the Elevate 52 UC trial, 27% of patients achieved clinical remission, compared to 7% of patients receiving a placebo at week 12, and by week 52 it was 32% versus 7%. In the Elevate 12 UC trial, remission rates were 26% versus 15% for patients receiving Velpisity versus a placebo.
Pfizer also noted that all the studies’ secondary endpoints, including endoscopic improvement and mucosal healing, were met at week 12.
Velsipity is the second sphingosine-1-phosphate (S1P) drug to hit the ulcerative colitis (UC) market. The FDA approved Bristol Myers Squibb’s Zeposia for the treatment of adults with moderately to severely active UC in May 2021.
“It’s important to have new, effective options like Velsipity for those patients who may require an advanced treatment option and prefer the convenience of a once-daily pill,” Michael Chiorean, co-director of the Swedish Medical Center’s IBD center and an investigator in the Elevate program, said in a statement. “Velsipity is a proven advanced treatment with a favorable benefit-risk profile.”
The study noted as well that adverse events were reported in 71% of patients receiving etrasimod versus 56% of patients receiving a placebo in the 52 UC trial, and 47% of patients in both groups in the 12 UC trial experienced adverse events, though “no deaths or malignancies were reported.”
The approval marks a return on investment for Pfizer, which completed its $6.7 billion purchase of Arena Pharmaceutical in March 2022. Etrasimod, which was the centerpiece of Pfizer’s December 2021 acquisition of Arena, was originally developed as part of its portfolio of therapies for immuno-inflammatory diseases.
Ulcerative colitis affects roughly 1.25 million Americans, Pfizer noted in its announcement, and its span of symptoms ranges from urgency to abdominal pain and chronic diarrhea with blood and mucus and beyond the physical “to other aspects of life due to the chronic and unpredictable nature of symptoms,” the company added.
“Velsipity’s FDA approval today marks a significant milestone for UC patients who need new treatments for this chronic condition and are ready to start advanced therapy,” Angela Hwang, president of Pfizer’s global biopharmaceuticals business division, said in a statement.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
