The FDA has decided not to designate hepatitis delta virus (HDV) as a tropical disease under the Federal Food, Drug, and Cosmetic Act, following a suggestion from Gilead Sciences. This decision indicates that the agency does not see a significant market for HDV treatments in developed nations.
In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatitis delta virus (HDV) infection meets the statutory criteria for designation as a "tropical disease" under Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Agency has analyzed whether there is "no significant market in developed nations" for drugs
Original title: “Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act”