ARTICLE | Clinical News

Intercept issues Ocaliva warning for liver-related AEs

September 15, 2017 5:32 PM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) issued a "Dear Health Care Provider" letter warning that liver-related adverse events have been reported in primary biliary cholangitis (PBC) patients receiving Ocaliva obeticholic acid (DSP-1747).

Ocaliva is an oral farnesoid X receptor (FXR; NR1H4) agonist that has accelerated approval in the U.S. to treat PBC in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The drug also has conditional approval in the EU for the indication...