BRIEF—FDA guidance to help with hep D drug development

There are no drugs approved by the US Food and Drug Administration (FDA) for the treatment of hepatitis D, but the agency wants to change this and has published guidance to help industry answer the call of patients.

Because chronic hepatitis D is a serious and life-threatening condition and there are no approved treatments, investigational drugs may be eligible for the FDA’s expedited programs such as fast track, breakthrough therapy, accelerated approval, and priority review designations.

The guidance addresses the FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics for the treatment of chronic hepatitis D, which only occurs in people with hepatitis B.