New IBD and ulcerative colitis drug gets FDA approval: ‘astonishing results’

A new drug intended to treat a type of inflammatory bowel disease (IBD) has received the green light from the Food and Drug Administration.

The FDA on Friday approved Pfizer’s etrasimod, branded as Velsipity, to treat adults with a chronic digestive disorder known as ulcerative colitis (UC).

The oral pill, taken once a day, was approved after a clinical trial showed a reduction in disease symptoms in patients taking the drug compared to those taking a placebo.

“There are a lot 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 some pretty amazing results” with the new drugs, Swaminath added. “I think if you look at the last few years, it’s been a game changer. »

Velsipity vs. Zeposia

For UC, the only comparable drug in Velsipity’s class of S1P receptor modulators is Zeposia (ozanimod), made by rival Bristol Myers Squibb.

Velsipity helped 27% of patients achieve remission of ulcerative colitis symptoms after 12 weeks of treatment, compared to about 7% of those taking a placebo.

And the difference in remission rates after one year increased by 25%, according to Fierce Pharma. In comparison, Zeposia showed a 19% benefit over placebo after one year of clinical trial.

As a pill, Velsipity may have an added advantage over other UC medications, such as so-called biologic treatments given by injection, because many people, including health care workers, are afraid of needles.

Due to the unpredictable nature of UC, people living with the disease may undergo several different treatments over time. Patients may also be apprehensive about using injectable therapies, such as biologics, Dr. Michael Chiorean, co-director of the Swedish Medical Center’s IBD Center, said in a news release.

It is important to have new, effective options like Velsipity for patients who may need an advanced treatment option and prefer the convenience of a once-daily pill,” added Chiorean.

What is ulcerative colitis?

According to the Mayo Clinic, ulcerative colitis is an IBD that causes inflammation and ulcers (open sores) in the innermost lining of the large intestine (the colon) and rectum.

(Another common type of IBD is known as Crohn’s disease, which can affect different areas of the digestive tract in different people, most commonly the small intestine.)

In 2023, the global prevalence of ulcerative colitis was estimated at approximately 5 million cases, and its incidence is increasing worldwide, according to the medical journal The Lancet.

Symptoms of ulcerative colitis

Symptoms of UC may include:

• Diarrhea, often accompanied by blood or pus
• Rectal bleeding
• Abdominal pain and cramps
• Rectal pain
• Urgency to defecate or inability to defecate despite the urgency
• Weightloss
• Fatigue
• Fever
• In children, a delay in normal growth

UC symptoms may go into remission for long periods of time. The causes of this disorder are not well understood, but it is thought that the immune system may not be working properly, causing it to attack cells in the digestive tract.

It can also be hereditary, and some studies show that it may be more common in people of Ashkenazi Jewish descent.

“There is a range of severity,” Swaminath said. Some people experience long periods of asymptomatic remission, “and then there are people who are so sick they are hospitalized for it.”

Treatment of ulcerative colitis

The range of UC medications includes anti-inflammatories such as corticosteroids, immune system suppressants, and biologics that target proteins produced by the immune system. In severe cases, surgery may also be a treatment option.

“There are an explosion of options for patients,” Swaminath said, “especially for patients who have difficulty with injections or infusions.”

“Matching the right treatment to the right patient” is the goal, he added, because new therapies allow patients to live full lives without thinking about their IBD. “Their colonoscopies seem improved or returned to normal. This is the outcome patients should be looking for.

UC can affect patients differently, and many people living with the disease suffer from persistent symptoms, said Michael Osso, president and CEO of the Crohns & 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 United States,” he added.