FDA Approves New Drug for Ulcerative Colitis

Officials say Zeposia could reduce symptoms of ulcerative colitis in adults. Pixels Effect/Getty Images

Federal regulators have approved the new drug Zeposia for treating moderate to severe ulcerative colitis in adults.The medication i…

Officials say Zeposia could reduce symptoms of ulcerative colitis in adults. Pixels Effect/Getty Images
  • Federal regulators have approved the new drug Zeposia for treating moderate to severe ulcerative colitis in adults.
  • The medication is the latest in a line of drugs used to treat symptoms of this particular type of inflammatory bowel disease (IBD).
  • Clinical trials are under way to test Zeposia's effectiveness in treating Crohn's disease.

If you’re living with ulcerative colitis, you may have a new treatment option.

On May 27, Bristol Myers Squibb officials announced that the Food and Drug Administration (FDA) approved Zeposia (ozanimod) for treatment of moderate to severe active ulcerative colitis in adults.

Ulcerative colitis is a chronic inflammatory bowel disease (IBD). Symptoms such as abdominal pain, diarrhea, and malnutrition can affect a person's quality of life.

Currently, the only potential cure for ulcerative colitis is surgery to remove the colon. But there are several types of medications to help manage the disease.

An estimated 3 million adults in the United States have been diagnosed with ulcerative colitis or Crohn’s disease, another type of IBD.

The FDA approved Zeposia in 2020 as a disease-modifying therapy for adults with relapsing forms of multiple sclerosis. And phase 3 trials are under way to evaluate the safety and efficacy of Zeposia for treating Crohn’s disease.

Clinical trial results

Approval of Zeposia was based on data from the True North study, a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial.

The study involved more than 600 people with ulcerative colitis who couldn’t take or hadn’t gotten a favorable response from oral aminosalicylates, corticosteroids, immunomodulators, or a biologic drug.

The participants were receiving treatment with oral aminosalicylates or corticosteroids before and during the induction period.

At 10 weeks, 18 percent of people taking Zeposia reached clinical remission. That compares to 6 percent in the placebo group. There was also significant improvement in secondary endpoints, including a clinical response of 48 percent versus 26 percent.

At 52 weeks, 37 percent of those in the Zeposia group were still in remission, compared with 19 percent of those in the placebo group. Clinical response was 60 percent versus 41 percent.

Corticosteroid-free clinical remission was 32 percent in the Zeposia group versus 17 percent in the placebo group.

Eligible participants are continuing in an open-label extension trial to evaluate longer term results.

What you need to know

Zeposia is an oral medication taken once a day. The dose is 0.92 milligrams.

Dr. Rudolph Bedford, a gastroenterologist at Providence Saint John’s Health Center in Santa Monica, told Healthline that Zeposia is a potential game changer for people with ulcerative colitis who don’t respond to traditional therapies.

“Traditional therapies include aminosalicylates along with corticosteroids and immunomodulators. They’re all oral therapies, but quite often there’s no response or an ineffective response, so we move on to biologics,” he said.

Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator.

“In ulcerative colitis and Crohn’s disease, T-cells attack the mucosal lining of the colon. This modulator regulates how that process occurs,” Bedford explained. “By essentially eliminating T-cells from moving into the lining of the colon, it prevents an inflammatory response with bleeding, diarrhea, and everything else that goes along with ulcerative colitis.”

“We’ve been looking forward to oral medications coming out that are completely different from what we’re used to,” he said. “I’m not sure it’s a first-line therapy at this point, but there will likely be more studies looking at this in naïve patients. I suspect that eventually the medical community will start to embrace it.”

“This is not the first oral drug, but it’s the first to target this particular receptor. Another oral therapy, Xeljanz (tofacitinib), targets a different receptor. It’s called a Janus kinase inhibitor and is used in patients with moderate to severe active ulcerative colitis,” said Bedford.

However, Zeposia isn’t for everyone with ulcerative colitis.

“My understanding is the biggest adverse effects are in certain patients who had myocardial infarction in the last 6 months, or other cardiac issues like unstable angina or heart failure. People who have had a stroke or TIA in the past 6 months shouldn’t take it,” he said.

The drug was also contraindicated (not recommended) in those who have:

  • Mobitz type II second-degree or third degree atrioventricular (AV) block
  • sick sinus syndrome
  • sino-atrial block, unless the person has a functioning pacemaker
  • severe untreated sleep apnea
  • people taking a monoamine oxidase (MAO) inhibitor

“The bottom line is that we’re moving in a profound direction in the treatment of inflammatory bowel disease in general,” said Bedford.

“We’re becoming much more sophisticated with targeted therapies for this particular disease process, and likely within the next 5 to 10 years or so will be moving further and further in this direction,” he said.