Forty years ago today (8 May 1980), the World Health Organization officially declared smallpox eradicated.
US regulators have approved the first treatment designed to mitigate the impact of a potential outbreak of smallpox caused by bioterrorism.
The guidance, which updates the agency's 2007 draft guidance Smallpox (Variola Virus) Infection: Developing drugs for Treatment or Prevention, discusses issues related to nonclinical development, study design considerations for animal efficacy studies and considerations for developing a human safety database.
Researchers investigated the efficacy of tecovirimat in nonhuman primate (monkeypox) and rabbit (rabbitpox) models in accordance with the Food and Drug Administration (FDA) Animal Efficacy Rule, which was interpreted for smallpox therapeutics by an expert advisory committee.
SIGA is slated to receive US Food and Drug Administration (FDA) approval for the world’s first antiviral drug to treat smallpox.
The drug prevents the variola virus from infecting other cells.
Although eradicated, research on smallpox continues due to its potential to be used in biological warfare.