US FDA revokes emergency use authorization of hydroxychloroquine for treatment of COVID-19

The results of our study, published in JAMA Pediatrics, was used to support the US FDA’s decision to revoke emergency use authorization of hydroxychloroquine for treatment of COVID-19. Our model-based analysis demonstrated that hydroxychloroquine concentrations in lung tissue may be too low to elicit an antiviral effect - raising concerns about use of hydroxychloroquine for treatment of COVID-19. This work epitomizes the impact that pharmacokinetic modeling and simulation can have on clinical care. The FDA communication can be found here.