FDA Approved VELSIPITY For Ulcerative Colitis

The FDA approved the new once-daily pill for ulcerative colitis based on favorable clinical trial results.

On October 13, Pfizer Inc. announced the FDA approval of VELSIPITY (etrasimod), the company's new oral treatment for ulcerative colitis (UC). VELSIPITY is a selective sphingosine-1-phosphate (S1P) receptor modulator approved for use in adults with moderate to severe active disease. The drug reduces the speed at which white blood cells enter the bloodstream.

The recommended dose for the new drug is two milligrams (mg), taken orally once a day.

The FDA approved VELSIPITY based on the results of the ELEVATE UC Phase 3 registrational program — ELEVATE UC 52 and ELEVATE UC 12. The program tested the safety and efficacy of the new drug on participants with UC who couldn't tolerate at least one conventional, biologic, or Janus kinase (JAK) inhibitor treatment or did not see improvement while taking these therapies.

According to Pfizer, both studies involving the drug achieved all primary and critical secondary efficacy endpoints, with a positive safety profile consistent with previous studies.

For example, in week 12 of the ELEVATE UC 52 trial, 27% of participants receiving VELSIPITY experienced clinical remission compared to 7% for patients receiving placebo. By week 52, 32% of participants treated with VELSIPITY went into remission compared to 7% of placebo participants.

The second trial — ELEVATE UC 12 — saw similar results, with 26% of participants taking the new drug experiencing remission versus 15% receiving the placebo.

The most common adverse side effects observed were:

• Headache
• Elevated liver tests
• Dizziness

More serious side effects were:

• Liver problems
• Increased blood pressure
• Macular edema, a condition that causes vision changes
• Certain types of skin cancer
• Shortness of breath

According to Reuters, VELSIPITY's price is $6,164 for a 30-day supply, which equals about $75,000 a year — a cost similar to other oral treatments like AbbVie's Rinvoq and Pfizer's Xeljanz.

What is ulcerative colitis?

Ulcerative colitis is an inflammatory bowel disease (IBD) primarily affecting the colon and is characterized by the presence of ulcers in the lining of the large intestine. Symptoms of UC include abdominal pain, diarrhea, and blood in the stool.

The exact cause of the disease is still not fully understood, but health experts believe it involves a combination of genetic, gut biome, immune system, and environmental factors.

This condition tends to have periods of flaring up with symptoms and periods of remission. While there is no known cure for ulcerative colitis, various treatments, including medication and lifestyle changes, can help manage its symptoms.