July 18, 2016
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has announced that the U.S. Food and Drug Administration (FDA) has approved PREZISTA® (darunavir) to be used during pregnancy and the postpartum period. Previously, a human immunodeficiency virus (HIV-1) protease inhibitor, PREZISTA® was indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV. Clinical data demonstrates that PREZISTA® taken with ritonavir has been found to be well-tolerated during pregnancy and the postpartum period.
No reports were found about mother-to-child HIV transmission among the 29 women who continued therapy through delivery. Nor were there any new clinically relevant safety findings compared with the known safety profile of PREZISTA®/ritonavir in HIV-1 infected adults.
Richard Nettles, Vice President, Medical Affairs, Janssen Therapeutics, said: “Many HIV treatments have limited data available to support their use during pregnancy. This expansion of our label is an important advancement in addressing the needs of women living with HIV, and it demonstrates that PREZISTA® is a safe and effective treatment for pregnant women living with this disease. We are proud to be able to provide an option for physicians and mothers who are trying to determine the best approach for HIV treatment.”