Gilead cleared to resume investigational HIV drug studies

May 17, 2022

Gilead has been cleared by the FDA to continue studies of its investigational HIV drug lenacapavir.

The regulatory setbacks came as a result of glass compatibility issues, after the FDA raised concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir.

The FDA has now cleared the studies after Gilead began storing the drug in an alternative vial made of aluminosilicate glass.

It is not the first time Gilead has faced particle woes. In December of last year, the company recalled two lots of Veklury, also known as remdesivir, after glass particulates were found in a vial.