FDA clears Pfizer's Xeljanz for inflammatory bowel disease
(Reuters) - The U.S.
(Reuters) - The U.S. Food and Drug Administration said on Wednesday that it had approved Pfizer Inc's drug, Xeljanz, to treat adults with moderate-to-severe active ulcerative colitis.
The effectiveness of Xeljanz in treating ulcerative colitis was shown in three controlled clinical trials, including two trials that showed the drug caused disease remission in about 17-18 percent of the patients.
The drug is already approved by the FDA to treat rheumatoid arthritis and psoriatic arthritis.
Xeljanz is expected to bring in sales of $2.16 billion in 2019, according to Thomson Reuters I/B/E/S. It had generated sales of $1.35 billion in 2017.
Ulcerative colitis is a chronic, inflammatory bowel disease that affects the colon and causes recurrent flares of abdominal pain and bloody diarrhea.
More than 900,000 people suffer from the disease in the United States, according to the FDA.
Pfizer's shares were up 1.1 percent at $36.11 in afternoon trading.
(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta and Anil D'Silva)
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