FDA rejects Intercept’s pitch for NASH as CEO fires back at the agency’s ‘evolving’ guidelines
In a major setback for an already ailing field, the FDA has rejected obeticholic acid, the Intercept Pharmaceuticals compound that would have been the first drug specifically approved to treat NASH.
The Intercept drug had, in February of 2019, yielded the first positive Phase III results for the obesity-related liver condition and its subsequent NDA submission was closely watched around the industry as the first test for how regulators would treat the nascent but fast-growing field.
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