FDA postpones decision on Intercept's lead liver drug

Reuters Health Information: FDA postpones decision on Intercept's lead liver drug

FDA postpones decision on Intercept's lead liver drug

Last Updated: 2015-12-18

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration has postponed by three months its decision on Intercept Pharmaceuticals Inc's marketing application for its lead drug, to treat a kind of liver disease.

The company's shares were down 6.6% at $155 in extended trading on Thursday.

Intercept said the FDA would hold an advisory committee meeting on April 7 and announce its decision on May 29 as it required more time to analyze additional clinical data submitted by the company.

The drug, obeticholic acid, is for primary biliary cirrhosis (PBC), a rare liver disease that results from autoimmune destruction of the bile ducts in the liver.

Intercept is seeking approval for the drug to be used in combination with the generic drug ursodeoxycholic acid.

The company is also conducting late-stage studies on the same drug to treat nonalcoholic steatohepatitis (NASH), which has no approved treatment.

The NASH indication remains the jewel in Intercept's pipeline.

"The obvious longer-term ICPT reality is this is a NASH story not a PBC story and expectations don't seem overly high for PBC," RBC analyst Michael Yee said in a note earlier this month.

"The bigger picture value creation will likely be driven by success in NASH."

After Gilead Sciences Inc hit the jackpot with its hepatitis C drugs, Sovaldi and Harvoni, drugmakers have been turning their attention to other liver diseases.

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