FDA expands Prezista indication

SILVER SPRING, Md. — The Food and Drug Administration has approved a bew indication for Janssen Therapeutics’ Prezista (darunavir), the company announced Monday. Prezista, a treatment for HIV-1 in adults and children older than 3 years of age, can now be used by pregnant women with HIV. 

 

“Many HIV treatments have limited data available to support their use during pregnancy,” Janseen Therapeutics VP medica affairs Richard Nettles said. “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.”