FDA greenlights label update to Gilead’s Biktarvy to include more data in pregnant people

The FDA on Friday approved a label update on Biktarvy, Gilead’s blockbuster HIV drug, to include more data on the drug’s safety and efficacy for pregnant people with HIV.

The additional data reflected on the label are supported by positive results from Gilead’s Study 5310, which evaluated Biktarvy in pregnant people with HIV-1 who have suppressed viral loads, meaning that they have a low level of virus in their bodies. The study evaluated people in their second and third trimesters through a median of 16 weeks postpartum.

Jared Baeten

“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant people with HIV, an often understudied and most vulnerable community in clinical research,” Jared Baeten, Gilead’s vice president of HIV clinical development, said in a statement. “Not only is Biktarvy an alternative regimen for use in pregnancy,…
Click here to view original post

Click Here to Publish/Feature Your Company or Product News with Biotech Networks