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Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC

 
• By Joseph Haas

The FXR agonist is the first new drug approved for primary biliary cholangitis in 19 years, but the lack of long-term outcomes data leaves a perceived opportunity for a host of mid-stage candidates also pursuing the indication. Intercept is conducting a Phase IV study to obtain such data with Ocaliva.

BOSTON – Ocaliva (obeticholic acid) became the first new drug to market for primary biliary cholangitis (PBC) in 19 years with its June launch in the US, but its indication as second-line therapy in a chronic condition left lots of treatment questions and potential safety gaps for other PBC candidates to target. Intercept Pharmaceuticals Inc. CEO Mark Pruzanski explained in a Nov. 15 interview during the American Association for the Study of Liver Diseases meeting that his company is working toward long-term outcomes data that might mitigate some of those perceived gaps.

Ocaliva is a bile acid analog that inhibits the farnesoid X receptor (FXR) and is in Phase III development for...

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