Details
The U.S. Food and Drug Administration (FDA) initiated a study in the Sentinel System to support the Office of Surveillance and Epidemiology’s active safety monitoring plan for therapeutics granted Emergency Use Authorization (EUA) status for the treatment of coronavirus disease 2019 (COVID-19). EUA authority allows FDA to strengthen the nation’s public health protections by authorizing unapproved medical products or unapproved uses of approved medical products during public health emergencies, such as the COVID-19 pandemic. One of these products, Paxlovid (nirmatrelvir/ritonavir), was granted EUA approval on December 22, 2021.
The FDA assessed Paxlovid in Sentinel while under EUA approval to understand the potential for drug-drug interactions. This assessment indicated that more than 50% of Paxlovid-eligible patients may have been on drugs that could interact with Paxlovid. However, most of the commonly used drugs that are involved in these drug-drug interactions with Paxlovid did not seem to prevent patients from taking Paxlovid, as they can be temporarily withheld or adjusted to a lower dose.
These findings were included in the FDA’s New Drug Application (NDA) review of Paxlovid, which emphasizes adverse reactions as a key component of the safety review. After reviewing the NDA information, the FDA included a boxed warning to the Paxlovid label to underscore the drug-drug interaction risk. On May 25, 2023, the FDA approved the NDA for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.