The most aggressive form of viral hepatitis has no FDA-approved oral treatment in the United States. That may change. The FDA has accepted a new drug application for lonafarnib for chronic hepatitis D, moving an investigational oral therapy into formal review for a disease that most Americans, including many who are at risk, have never heard of.
EIT Pharma announced its acceptance in a statement this week. Acceptance means the agency has determined the application is complete enough to review. It is not an approval, and the company did not disclose a target action date.
