The FDA approved oral Etrasimod (Velsipity) on Friday for treating moderately to severely active ulcerative colitis (UC) in adults, drugmaker Pfizer announced.

Approval of the selective sphingosine-1-phosphate (S1P) Receptor Modulator was supported by the phase III ELEVATE UC program, which together included nearly 800 patients who had failed or were intolerant of prior treatment, including either a conventional drug, a biologic, or a Janus kinase (JAK) inhibitor.

Of note, two-thirds of the trial participants were naive to either biologic therapy or a JAK inhibitor, and 7% of enrolled patients had isolated proctitis.

In the ELEVATE UC 52 study, 27% of patients on the recommended dose of etrasimod (2 mg once-daily) achieved clinical remission at the end of the 12-week induction period, as compared with just 7% of those assigned to placebo. By week 52, this stretched to 32% versus 7%, respectively (PP

All key secondary endpoints in the trials — including endoscopic improvement and mucosal healing — were met as well.

“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time. Patients may also be apprehensive about using injectable therapies, like biologics,” said ELEVATE investigator Michael Chiorean, MD, of the IBD Center at Swedish Medical Center in Issaquah, Washington, in a statement from the drugmaker.

“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,” added Chiorean.

Common adverse events in the trials (5% or greater) included headache, elevated liver enzymes, and dizziness.

Etrasimod — which selectively binds with S1P receptor subtypes 1, 4, and 5 — is not the first S1P receptor modulator approved for UC. That distinction goes to ozanimod (Zeposia) — which binds to receptor subtypes 1 and 5 — and was approved in 2021 for the same indication. The drugs are believed to reduce lymphocyte migration into the intestines, though their exact mechanism is unknown.

Unlike ozanimod, however, etrasimod does not require a 7-day dosage uptitration period to reduce the risk for cardiac effects. But before starting therapy, it’s still recommended that patients talk to their physicians if they have a slow heart rate, arrhythmia, hypertension, heart disease, or a history of myocardial infarction, stroke, or a transient ischemic attack, among other conditions, as treatment may be contraindicated in some of these cases.

Labeling for etrasimod includes warnings over the risks of bradyarrhythmia when first initiated and of serious infections; live vaccines should be avoided at least 4 weeks before starting the S1P receptor modulator. Drug-drug interactions may occur with beta-blockers, calcium channel blockers, and medications that affect the immune system, and etrasimod is contraindicated in patients on rifampin or fluconazole.

Other serious side effects noted in the labeling included liver problems, increased blood pressure, macular edema, skin cancers, posterior reversible encephalopathy syndrome, and breathing problems.