Intercept's Ocaliva Eyes Vacant Ground In Europe
Intercept is gearing for launch in Europe following the CHMP's positive opinion for Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis, an indication for which there is currently only one approved medication in Europe.
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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.
How to make the most of the wealth of raw data in pharmaceutical R&D is an increasing challenge for the industry. The digital revolution is already having an impact in areas like clinical trials, and pharma is also starting to embrace new technologies in drug discovery.
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