CHMP backs Ocaliva, Venclyxto

EMA's CHMP recommended conditional approval of both Ocaliva obeticholic acid to treat primary biliary cholangitis and Venclyxto venetoclax as monotherapy to treat chronic lymphocytic leukemia (CLL).

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) markets Ocaliva. The committee recommended its approval in combination with ursodeoxycholic acid (UDCA) in patients with inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. In May, FDA granted accelerated approval to the oral farnesoid X receptor (FXR; NR1H4) agonist for the same indication (see BioCentury Extra, May 31). ...