• 17 Oct 2023
• Admin
• News Article

Pfizer receives US FDA approval for ulcerative colitis drug

Pfizer Inc last week announced that the US FDA has approved its new ulcerative colitis drug etrasimod, which the company will market under the name Velsipity. It is an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis. The approved recommended dose for Velsipity is 2 milligrams.

Ulcerative colitis is a condition that leads to ulcers and causes abdominal pain, bloody stools and incontinence. It affects around 1.25 million people in the United States, according to the company statement.

Global market for inflammatory bowel diseases is about $20 billion and making it a lucrative target for the drug makers.

The drug, branded as Velsipity and chemically known as etrasimod, was the key asset that Pfizer picked up in its $6.7 billion deal for Arena Pharmaceuticals in last year.

Velsipity is the second sphingosine-1-phosphate drug to hit the ulcerative colitis market. In May 2021, the US FDA approved Bristol Myers Squibb’s Zeposia for the treatment of adults with moderately to severely active ulcerative colitis.

The introduction of a new treatment for ulcerative colitis disease could increase options for patients.

Ulcerative colitis disease affects roughly 1.25 million people in the United States, and its span of symptoms ranges from urgency to abdominal pain and chronic diarrhea with blood and mucus and beyond the physical to other aspects of life due to the chronic and unpredictable nature of symptoms.

Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of velsipity, the company said in an announcement. In the Elevate 52 ulcerative colitis clinical trial, 27 per cent of patients achieved clinical remission, compared to 7 per cent of patients receiving a placebo at week 12, and by week 52 it was 32 per cent versus 7 per cent. In the Elevate 12 ulcerative colitis clinical trial, remission rates were 26 per cent versus 15 per cent for patients receiving velpisity versus a placebo.

Nearly two-thirds of patients in Elevate ulcerative colitis phase III registrational programme, consisting of the Elevate ulcerative colitis 52 and Elevate ulcerative colitis 12 clinical trials, examined the safety and efficacy of a 2 milligrams daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy, and and these studies were also the only studies for advanced therapies for ulcerative colitis, including patients with isolated proctitis.