Pfizer
said Friday that the Food and Drug Administration had approved its new ulcerative colitis pill etrasimod, which the company will market under the name Velsipity.
The approval is one of a number of new product launches for
Pfizer
in the second half of this year, including a respiratory syncytial virus vaccine for expectant mothers. Pfizer (ticker: PFE) shares are down 36% so far in 2023 as a result of uncertainty about the long-term value of the company’s Covid-19 vaccine franchise.
The FDA approved Velsipity to treat “moderately to severely active ulcerative colitis in adults,” it said. Ulcerative colitis is a chronic condition that can cause chronic diarrhea, among other symptoms.
In one Phase 3 trial, 32% of patients on Velsipity experienced clinical remission after a year, compared to 7% on a placebo.
Pfizer said in a presentation last year that it projects global revenue from Velsipity in ulcerative colitis to peak at between $1 billion and $2 billion. It is one of a number of new products that the company expects to bring a combined $20 billion in potential annual revenue by 2030.
“VELSIPITY provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill that has a favorable benefit-risk profile,” Pfizer chief commercial officer Angela Hwang said in a Friday morning statement.
Pfizer obtained Velsipity as part of its 2022 acquisition of Arena Pharmaceuticals, a $6.7 billion deal. It is a member a class of drugs known as sphingosine 1-phosphate receptor modulators, which are also used as multiple sclerosis treatments. The FDA approved
Bristol Myers Squibb’s
(BMY) sphingosine 1-phosphate receptor Zeposia as an ulcerative colitis treatment in 2021.
Write to Josh Nathan-Kazis at [email protected]
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