BRIEF—Align with EMA on NASH, FDA urged

Pharma companies developing NASH treatments have responded to the most recent draft guidance for non-alcoholic steatohepatitis (NASH) with compensated cirrhosis, issued by the US Food and Drug Administration (FDA).

NASH drugmakers have asked the FDA to align its recommendations with the European Medicines Agency guidance regarding the development of NASH treatments, with the lack of alignment potentially disincentivizing sponsors to invest in research.

Companies’ comments to the FDA also included criticism that the latest NASH draft guidance does not allow for the accelerated approval pathway.