FDA News: Issue 14, June 2020

Author: [AUTHOR] Published on 6/23/2020 1:03:00 PM

New Spotlight on CDER Science: Linking In Vitro Antiviral Data to the In Vivo Setting in the Fight Against COVID-19

Identification of potentially effective and safe drug candidates with antiviral activity against the SARS-CoV-2 virus, the virus that causes COVID-19, is occurring at an unprecedented speed. The new Spotlight on CDER Science article entitled "Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-19" highlights the steps necessary for linking in vitro antiviral activity to in vivo drug exposure/concentration for appropriate dosing regimen design for COVID-19.

Translating in vitro antiviral activity to the in vivo setting is complex and multifactorial, but essential to finding the right products, administered at the right doses, to the right patients, at the right time for successful treatment of COVID-19. Multiple experimental factors can influence the estimation of antiviral potency, expressed as EC50, the drug concentration in cell culture media that provides 50% maximal antiviral activity. These factors, as well as unique pharmacokinetic and physiochemical characteristics of drugs under study, must be considered when evaluating the potential utility of a drug to treat a new indication such as COVID-19. This Spotlight on CDER Science article emphasizes the importance of sound PK modeling and accurate in-vitro-to-in-vivo translation of data in the appropriate design of dosing regimens administered in clinical trials for COVID-19.

The new Spotlight on CDER Science article entitled "Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-19" can be found at https://www.fda.gov/drugs/news-events-human-drugs/translating-vitro-antiviral-activity-vivo-setting-crucial-step-fighting-covid-19. Additional information on translating in vitro antiviral activity to support dosing regimens for COVID-19, specifically examining the case of hydroxychloroquine, is described in the following publication: "Connecting hydroxychloroquine in vitro antiviral activity to in vivo concentration for prediction of antiviral effect: a critical step in treating COVID-19 patients" at https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa623/5841401.

For information on the COVID-19 pandemic, visit the FDA Coronavirus Disease 2019 (COVID-19) website at https://go.usa.gov/xwXAF and the CDC Coronavirus (COVID-19) website at https://go.usa.gov/xwXAS.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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