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FDA Panel Backs Pfizer's Xeljanz as Bowel Disease Treatment


March 09, 2018

By Reuters Staff

(Reuters) - Pfizer Inc's Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis, a chronic bowel disease, a U.S. Food and Drug Administration (FDA) advisory committee concluded on Thursday.

The 15-member panel voted unanimously in favor of the drug. The FDA is not obliged to follow the recommendations of its advisory panels, but typically does.

Xeljanz, which is already approved to treat rheumatoid arthritis and psoriatic arthritis, raked in $1.35 billion in 2017 sales for Pfizer.

Ulcerative colitis is a chronic condition triggered by an abnormal immune response that creates long-lasting inflammation and ulcers in the large intestine lining. It is the most common inflammatory bowel disease.

Analysts at BMO Capital Markets expect Xeljanz to have sales of $3.5 billion in 2021, with ulcerative colitis accounting for about 10 percent.

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