The US Food and Drug Administration and sponsors of two new accelerated approval drugs for primary biliary cholangitis appear to have taken steps to avoid some of the problems that tripped up the confirmatory trial for Intercept Pharmaceuticals, Inc.’s Ocaliva (obeticholic acid).
Sponsors Aim To Avoid Confirmatory Trial Hurdles That Plagued Ocaliva In Primary Biliary Cholangitis
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion.
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