Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva ... which agreed that the farnesoid X receptor (FXR) agonist did not have a favorable benefit ...

Then came the 2016 accelerated approval of the farnesoid X receptor (FXR) agonist obeticholic acid (Ocaliva) as a second-line treatment for adults with PBC, either in combination with UDCA for ...

The European Commission has approved Intercept’s Ocaliva (obeticholic acid) for the liver disease ... a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at ...

Intercept Pharma's hopes of getting its non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA ... it remains on track to resubmit the FXR agonist in its lead indication of fibrosis ...

According to the CRL, the FDA is continuing to assess the safety data and is therefore not able to approve the sNDA in its current form. The Food and Drug Administration (FDA) has issued a ...

Advanz Pharma’s liver disease drug Ocaliva (obeticholic acid ... Ocaliva functions as a selective and potent farnesoid X ...

About Ocaliva ® (obeticholic acid) OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with ...

In September, the European Commission revoked obeticholic acid's marketing authorization for PBC. The FDA in 2016 granted ...