Ulcerative Colitis Drug Etrasimod (Velsipity) Gets FDA Approval
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Adults with moderately to severely active ulcerative colitis (UC) have a new treatment option with the U.S. Food and Drug Administration’s (FDA) recent approval of the oral medication etrasimod (Velsipity).
This once-a-day pill, manufactured by Pfizer, joins Bristol Myers Squibb’s ozanimod (Zeposia) to become the second UC treatment in a class of medications called S1P receptor modulators.
The FDA granted approval based on studies evaluating Velsipity as an advanced therapy for UC patients who need new treatments for this chronic condition. Clinical trials demonstrated the safety and efficacy of the drug in patients who had previously failed or were intolerant to other UC treatments — meaning at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
In research published in The Lancet involving more than 400 UC patients, 27 percent receiving Velsipity achieved clinical remission (where the symptoms of IBD have lessened to the point that they’re mostly absent or gone) compared with 7 percent receiving a placebo after 12 weeks. At week 52, the percent in the drug group achieving remission rose to 32 percent, while the placebo remission rate remained the same at 7 percent.
Velsipity Is a New Steroid-Free Medication for UC
Hundreds of thousands of Americans cope with the symptoms of ulcerative colitis, according to the National Institute of Diabetes and Digestive and Kidney Diseases, which include diarrhea, bloody stools, and cramping or pain in the abdomen. Existing medications, however, don’t work for all patients or they lose effectiveness over time.
“This drug is exciting news because it expands the toolbox of medications for patients with ulcerative colitis,” says Victor Chedid, MD, a gastroenterologist with the Mayo Clinic who specializes in treating patients with inflammatory bowel disease (IBD).
Dr. Chedid adds that the drug provides a possible way for patients to achieve clinical remission without the use of steroids, which have been used as a short-term treatment for IBD flares for decades.
“Steroids are not great for long-term UC treatment because they have a lot of side effects associated with them, such as complications related to bone health [osteoporosis], diabetes, changes in blood sugar, anxiety, mood disorder, and insomnia,” he says.
Chedid, who is not involved in the drug research, adds that Velsipity is convenient compared with biologics, which usually require an infusion or injection.
Medicine Helps the Immune System Work More Effectively
Velsipity is a type of drug called a selective sphingosine-1-phosphate (S1P) receptor modulator.
These medications are called immunomodulators because they alter how the immune system functions so it works more effectively. The drugs bind to proteins called sphingosine 1-phosphate (S1P). S1P receptors are found on the surface membranes of T-cells and B-cells, which are immune cells. This action reduces the level of inflammation in people with ulcerative colitis.
A difference between Velsipity and Zeposia is in its dosing. Zeposia requires titration where the dosing is gradually increased over the first few days, whereas the daily dose of Velsipity is set at 2 milligrams.
Risks and Benefits of S1P Receptor Modulators
While both Velsipity and Zeposia have a favorable “risk-benefit profile,” Chedid warns that the therapies can affect the heart.
“What you worry about with these S1P receptor modulators is slow heart rate [or bradyarrhythmia],” he cautions.
Because of this possible side effect, patients must have an electrocardiogram (ECG) to check the heart’s electrical activity before taking a first dose.
How Much Do These Ulcerative Colitis Drugs Cost?
Medications like Velsipity and Zeposia can be “quite expensive,” according to Chedid. Velsipity, which is expected to be available in late November, has an estimated wholesale acquisition cost of $6,164 for a 30-day bottle ($75,000 a year), according to Managed Healthcare Executive. The list price for Zeposia is $8,386.66 for a 30-day supply.
“No matter the cost, drugs like this are making the treatment of ulcerative colitis more efficacious and hopefully reducing the complications that are associated with the disease and the suffering that patients might have,” says Chedid.
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