A new drug for treating a type of inflammatory bowel disease (IBD) has been given the go-ahead by the Food and Drug Administration.
On Friday, the FDA approved Pfizer’s etrasimod, branded as Velsipity, for treating adults with the chronic digestive disorder known as ulcerative colitis (UC).
The oral, once-daily pill was granted approval after a clinical trial showed a reduction in disease symptoms for patients who took the drug compared with those who took a placebo.
“There’s a large number of therapies” now available for ulcerative colitis, Dr. Arun Swaminath, director of the IBD program at Lenox Hill Hospital, told The Post.
“We’re seeing pretty amazing results” with the newer drugs, Swaminath added. “I think if you look over the last few years, it’s been game-changing.”
Velsipity vs. Zeposia
For UC, the only comparable drug in Velsipity’s class of S1P receptor modulators is Zeposia (ozanimod), made by competitor Bristol Myers Squibb.
Velsipity helped 27% of patients achieve remission of ulcerative colitis symptoms after 12 weeks on the drug, versus about 7% for those taking a placebo.
And the difference in remission rates after one year was increased by 25%, according to Fierce Pharma. By comparison, Zeposia showed a 19% advantage over placebo after one year in its clinical trial.
As a pill, Velsipity may have an additional advantage over other drugs for UC like so-called biologic treatments that are given by injection, since many people — including health care workers — have a fear of needles.
“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,” Dr. Michael Chiorean, co-director of the IBD Center at Swedish Medical Center, said in a news release.
“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,” Chiorean added.
What is ulcerative colitis?
Ulcerative colitis is an IBD that causes inflammation and ulcers (open sores) in the innermost lining of your large intestine (the colon) and the rectum, according to the Mayo Clinic.
(Another common type of IBD is known as Crohn’s disease, which can involve different areas of the digestive tract in different people, most commonly the small intestine.)
In 2023, the global prevalence of ulcerative colitis was estimated to be about 5 million cases, and the incidence is increasing worldwide, according to the medical journal The Lancet.
Symptoms of ulcerative colitis
Symptoms of UC may include:
- Diarrhea, often with blood or pus
- Rectal bleeding
- Abdominal pain and cramping
- Rectal pain
- Urgency to defecate, or an inability to defecate despite urgency
- Weight loss
- Fatigue
- Fever
- In children, a failure to grow normally
Symptoms of UC can go into remission for lengthy periods of time. The causes of the disorder aren’t well understood, but it’s believed that the immune system may be functioning improperly, causing it to attack the cells in the digestive tract.
It also can run in families, and some studies show it can be more common among people of Ashkenazi Jewish descent.
“There’s a range for how serious it can be,” Swaminath said. Some people experience lengthy periods of asymptomatic remission, “then there are people who are so sick that they’re hospitalized for it.”
Ulcerative colitis treatment
The range of medications for UC includes anti-inflammatory drugs such as corticosteroids, immune system suppressors and biologics that target proteins made by the immune system. In severe cases, surgery may also be a treatment option.
“There’s an explosion of options for patients,” Swaminath said, “especially for patients who have a hard time with injections or infusions.”
“Matching the right treatment to the right patient” is the goal, he added, since new therapies allow patients to lead a full life without thinking about their IBD. “Their colonoscopies either look improved or back to normal. That’s the endpoint that patients should be looking for.”
“UC can affect patients differently and many people living with this disease struggle with ongoing symptoms,” said Michael Osso, President and CEO of the Crohn’s & Colitis Foundation.
“The introduction of a new treatment for UC could increase options for patients, and we look forward to seeing the impact of Velsipity for patients across the US,” he added.