The FDA might have shifted the goalposts in NASH
Yesterday, Intercept Pharmaceuticals revealed that the FDA rejected its treatment for NASH, a prevalent fatty-liver disease. But the implications could go far beyond a single company, changing the definition of success in one of the drug industry’s biggest targets.
As STAT’s Adam Feuerstein reports, Intercept’s drug significantly reduced liver scarring, a hallmark of NASH, in a pivotal trial. But that wasn’t enough to convince the FDA, which concluded that the “predicted benefit” of the company’s drug “does not sufficiently outweigh the potential risks,” Intercept said in a statement.
That could mean that the FDA is unwilling to approve NASH treatments based on scarring alone, which would affect a multitude of drugs in development. Conversely, the rejection could stem from an issue specific to Intercept’s drug. Until there’s more information, no one can be sure.
Read more.
As STAT’s Adam Feuerstein reports, Intercept’s drug significantly reduced liver scarring, a hallmark of NASH, in a pivotal trial. But that wasn’t enough to convince the FDA, which concluded that the “predicted benefit” of the company’s drug “does not sufficiently outweigh the potential risks,” Intercept said in a statement.
That could mean that the FDA is unwilling to approve NASH treatments based on scarring alone, which would affect a multitude of drugs in development. Conversely, the rejection could stem from an issue specific to Intercept’s drug. Until there’s more information, no one can be sure.
Read more.
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