Intercept Pharmaceuticals Gets Orphan Drug Status for OCA and Bezafibrate to Treat Primary Biliary Cholangitis

By Mary de Wet

Intercept Pharmaceuticals said Tuesday it received the Food and Drug Administration's orphan drug designation for a combination of obeticholic acid and bezafibrate to treat a rare bile-duct disease.

Intercept has two Phase 2 studies to explore a range of therapeutic doses for the combination of OCA and bezafibrate, the biopharmaceutical company said.

The company expects to complete interim analyses from the studies later this year.

The orphan-drug designation was given for a fixed dose to treat primary biliary cholangitis, a chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women over the age of 40.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Write to Mary de Wet at [e-mail]

(END) Dow Jones Newswires

May 16, 2023 17:59 ET (21:59 GMT)

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