IMPAACT 2032 evaluates the pharmacokinetics and safety of remdesivir for treatment of COVID-19 in pregnant and non-pregnant individuals in the United States.
On 12 June 2023, the U.S. Food & Drug Administration approved a supplemental new drug application (sNDA) from Gilead Sciences, Inc. that provided pharmacokinetic and safety data from pregnant individuals with COVID-19 treated with remdesivir. This supplement included data from the Phase 4 study IMPAACT 2032*. This labeling update follows the FDA’s expanded approval of remdesivir for treating pediatric patients 28 days and older with COVID-19 in April 2022.
On 22 June 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted a positive opinion supporting the proposed updates to the label based on the IMPAACT 2032 study. The product label has been updated to note that available clinical trial data has not identified a drug-associated risk of adverse maternal or fetal outcomes with the use of remdesivir in the second and third trimesters of pregnancy but that there are insufficient pregnancy data to evaluate the risk during the first trimester.
*IMPAACT 2032 was a Phase IV, open-label, randomized opportunistic study of the pharmacokinetics and safety of remdesivir in pregnant and non-pregnant individuals to treat COVID-19.