FDA approves Pfizer’s Velsipity as ‘oral, once-daily pill’ for ulcerative colitis
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The FDA has approved Pfizer’s 2 mg once-daily Velsipity, an oral, selective sphingosine-1-phosphate receptor modulator, to treat adult patients with moderately to severely active ulcerative colitis, according to a company press release.
This approval designates Velsipity (etrasimod) as only the second S1P receptor modulator available for the treatment of UC since Zeposia (Ozanimod, Bristol Myers Squibb) was approved for the indication in 2021.
“Velsipity provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill that has a favorable benefit-risk profile,” Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer, said in the release. “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.”
The FDA based its decision on data from the phase 3 ELEVATE UC registrational program, including the randomized, double-blind, placebo controlled ELEVATE UC 52 and ELEVATE UC 12 trials. The program evaluated the efficacy and safety of etrasimod 2 mg once-daily on clinical remission (defined by the 3-domain, modified Mayo score) in patients with UC. Nearly two-thirds of patients in each trial were naïve to either biologic or Janus kinase inhibitor therapy.
“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time,” Michael V. Chiorean, MD, co-director of the IBD Center at the Swedish Medical Center and an investigator in the ELEVATE Registrational Program, said in the release. “Patients may also be apprehensive about using injectable therapies, like biologics. 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.”
Results from ELEVATE UC 52 demonstrated that, at week 12, 27% of patients who received etrasimod achieved clinical remission compared with 7% of patients who received placebo; at week 52, 32% of patients achieved clinical remission vs. 7% in the placebo group.
In the ELEVATE UC 12 trial, 26% of patients who received etrasimod achieved clinical remission at week 12 vs. 15% of those who received placebo. Secondary efficacy endpoints including endoscopic improvement and mucosal healing were achieved at week 12, the release stated.
The company noted the safety profile of etrasimod is similar to that of previous studies, with common adverse reactions such as headaches, elevated liver tests and dizziness. Serious side effects may include infections and a slow heart rate.
Perspective
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Katherine Falloon, MD
The armamentarium of treatments available for inflammatory bowel disease continues to expand, with etrasimod among the latest medications to be approved for induction and maintenance of remission in patients with UC.
Etrasimod belongs to a class of medications known as shingosine-1-receptor modulator antagonists, which work via alterations in signaling pathways that lead to decreased circulation of lymphocytes. Etrasimod is the second medication in this class to be approved — the first, ozanimod, was approved in 2021. Of note, there are no head-to-head comparisons of etrasimod vs. ozanimod; however, etrasimod does have a shorter washout period, which is of benefit for patients who need to stop the medication, such as in anticipation of family planning.
Overall, greater choice for patients and providers is always beneficial, and etrasimod boasts a favorable safety profile. The fact that it is an oral formulation is also ideal, as many patients wish to avoid infusion or injection medications. However, it is important to note that most patients in ELEVATE UC 12 and ELEVATE UC 52 were naïve to biologics and other advanced therapies and a substantial proportion of patients were not in remission at the end of the study period.
I look forward to seeing more real-world data regarding the use of etrasimod in UC patients, as well as emerging data regarding its role in the treatment of patients with Crohn’s disease.
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