FDA Guidance Calls for Rapid Development of Hepatitis D Treatments

A new draft guidance from the FDA encourages drugmakers to speed up development of Hepatitis D treatments for use in the U.S., offering recommendations for innovative trial designs, target populations and endpoints.

Hep D is prevalent in third-world regions, but the draft guidance calls on sponsors to include U.S. populations in trials in anticipation of potential global spread of the virus.

Because there are no approved treatments for the life-threatening disease, the agency is interested in applications that qualify for accelerated approval through its fast-track, breakthrough therapy and priority review pathways.