FDA ANNOUNCES DRAFT GUIDANCE ON DEVELOPING DRUGS FOR HEPATITIS D INFECTION

FDA ANNOUNCES DRAFT GUIDANCE ON DEVELOPING DRUGS FOR HEPATITIS D INFECTION

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled, “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” This draft guidance will assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection. HDV infection occurs only in people who have hepatitis B virus (HBV) infection. 

Chronic HDV infection can impair liver function and cause long-term liver problems, including liver scarring, liver failure and cancer. These liver-related complications are more common in people who have HBV/HDV coinfection compared to people with HBV infection alone.  There are no FDA approved drugs for the treatment of HDV infection.  Because chronic HDV infection is considered serious and life-threatening condition and there are no FDA approved treatments, investigational anti-HDV drugs may be eligible for FDA’s expedited programs such as fast track, breakthrough therapy, accelerated approval, and priority review designations.

This draft guidance addresses the FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics for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 HDV infection. Sponsors are encouraged to communicate with the FDA Center for Drug Evaluation and Research’s Division of Antiviral Products (DAVP) about the development of drugs to treat HDV infection. This draft guidance is intended to serve as a focus for continued discussions among DAVP, pharmaceutical sponsors, the academic community and the public.

The FDA is seeking comments and suggestions on this draft guidance via the associated docket (Docket number: FDA-2019-D-4042). For more information, please refer to the draft guidance.

Find additional information in the Federal Register Notice