New drug to treat IBD and ulcerative colitis approved by FDA: Amazing results

Medicine

Via Marc Lallanilla

A new drug to treat a type of inflammatory bowel disease (IBD) has been approved by the Food and Drug Administration.

On Friday, the FDA approved Pfizers etrasimod, brand name Velsipity, to treat adults with a chronic digestive disorder called ulcerative colitis (UC).

The once-daily pill was approved after a clinical trial showed patients taking the drug had reduced symptoms compared to those taking a placebo.

Dr. Arun Swaminath, director of the IBD program at Lenox Hill Hospital, told The Post that there are many treatments available for ulcerative colitis.

“We have been getting pretty great results with the newer drugs,” Swaminath added. I think if you look back over the last few years, the game has changed.

Velsipity vs. Zeposia

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

Velsipity helped 27% of patients relieve their ulcerative colitis symptoms after 12 weeks of taking the drug, compared with about 7% of those taking a placebo.

And the difference in remission rates after one year increased to 25%, according to Fierce Pharma. By comparison, Zeposia showed a 19% advantage over placebo after one year of clinical testing.

As a pill, Velsipity may have additional advantages over other drugs for UC such as so-called biologic treatments that are administered by injection, because many people, including healthcare workers, are afraid of needles. injection.

Due to the unpredictable nature of UC, people with the disease may undergo many different treatments over time. Dr. Michael Chiorean, co-director of the IBD Center at Swedish Medical Center, said in a press release that patients may also be apprehensive about using injectable therapies, such as biologics.

It’s 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, Chiorean added.

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 (colon) and rectum.

(Another common type of IBD is called Crohns disease, which can involve different areas of the digestive tract in different people, most commonly the small intestine.)

According to the medical journal The Lancet, by 2023, the global incidence of ulcerative colitis is estimated at about 5 million cases, and the incidence of this disease is increasing worldwide.

Symptoms of ulcerative colitis

Symptoms of UC may include:

• Diarrhea, often containing blood or pus
• Rectal bleeding
• Abdominal pain and cramps
• Rectal pain
• Urgent defecation or inability to defecate despite urgency
• Losing weight
• Tired
• Fever
• In children, failure to develop normally

Symptoms of UC may be relieved for long periods of time. The cause of this disorder is not well understood, but it is believed that the immune system may not function properly, causing it to attack cells in the digestive tract.

It can also run in families, and some research suggests it may be more common in people of Ashkenazi Jewish descent.

Swaminath said there are different levels of severity. Some people go through long periods of symptom-free remission, and then others get so sick that they have to be hospitalized for their illness.

Treatment of ulcerative colitis

Medications to treat UC include anti-inflammatory drugs such as corticosteroids, drugs that suppress the immune system, and biologics that target proteins made by the immune system. In severe cases, surgery may also be a treatment option.

There are many options available to patients, especially for those who have difficulty with injections or infusions, Swaminath said.

Matching the right treatment to the right patient is the goal, he added, as new therapies allow patients to live full lives without thinking about their IBD. Their endoscopy looked improved or returned to normal. That is the endpoint that patients should be looking for.

Michael Osso, President and CEO of the Crohns & Colitis Foundation, said UC can affect patients differently, and many people with the condition struggle with ongoing symptoms.

“Introducing a new treatment for UC could increase options for patients, and we look forward to seeing the impact of Velsipity on patients across the United States,” he added.