Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC
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.
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Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US
Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.
Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk
Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.
Endpoint Selection Could Help Determine The NASH Race
Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.