NASH therapies head toward landmark approval

Drugs targeting metabolic drivers of fatty liver disease show promise at resolving inflammation, reducing damage and reversing fibrosis.

On 19 May, advisors to the US Food and Drug Administration (FDA) will meet virtually to discuss whether the antifibrotic benefits of a drug called Ocaliva from Intercept Pharmaceuticals outweigh the toxicity risks for patients with this common fatty liver disease. A full regulatory decision is expected a month later. Approval of a second drug, resmetirom from Madrigal Pharmaceuticals, could soon follow.