FDA Releases Draft Guidance on Antiviral Drug Development

Drugmakers should conduct nonclinical studies of antiviral drug candidates before initiating Phase I clinical trials, according to an FDA draft guidance.

The guidance, "Antiviral Drug Development -- Conducting Virology Studies and Submitting the Data to the Agency," outlines parameters for submitting nonclinical and clinical virology data to support the review of investigational antiviral drugs.

Regarding nonclinical studies, the guidance recommends drugmakers consider studies that identify the mechanism of action, establish specific antiviral activity of the compound in a model system and provide data on the development of viral resistance to the drug candidate. Additionally, antiviral candidates to be used in combination with other drugs should be subjected to in vitro combination activity studies to identify possible negative interactions, the agency says.

Regarding clinical studies, the FDA strongly recommends comprehensive resistance testing be undertaken in all phases of drug development. Plans to monitor the development of resistant viruses should be submitted to the FDA before clinical studies begin, the guidance says. These plans should be included in the nonclinical studies and in the overall clinical development plan contained in the investigational new drug application, according to the guidance.

The FDA will accept public comment on the draft guidance for 60 days. To view the document, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005-0183-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2005-0183-gdl0001.pdf).