US FDA approves Pfizer's inflammatory bowel disease drug

[October 14, 2023]  By Khushi Mandowara

(Reuters) -The U.S. Food and Drug Administration has approved Pfizer's drug to treat adults with an inflammatory bowel disease called ulcerative colitis, the company said on Friday.

The decision was based on data from a late-stage study that showed a reduction in disease symptoms for some patients who took the drug, when compared with the placebo.

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 last year.

Velsipity belongs to a class of drugs used to regulate the body's immune response and it is expected to compete with Bristol Myers Squibb's Zeposia, which was approved in 2021.

Pfizer said the wholesale acquisition cost of Velsipity per bottle is $6,164 for a 30-day supply, adding that it is consistent with other ulcerative colitis treatments currently on the market.

While, the list price of Zeposia for a 30-day supply is $8,386.66, according to Bristol Myers Squibb's website.

A company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. REUTERS/Johanna Geron/File Photo

Unlike Zeposi, Pfizer's Velsipity is approved by the U.S. regulator to be used without a requirement for patients to undergo laboratory test called titration before initiating treatment. This should be viewed as positive, said Leerink's analyst David Risinger in a note.

The risk-adjusted sales of Pfizer's drug by 2030 is estimated to be $2.2 billion, Risinger added.

Globally, the market for inflammatory bowel diseases is about $20 billion, making it a lucrative target for drugmakers.

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 Pfizer.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Arun Koyyur, Devika Syamnath and Shweta Agarwal)

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