Gilead granted FDA nod to resume HIV studies for injectable lenacapavir
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Gilead Sciences (NASDAQ:GILD) announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold imposed on the companyâs Investigational New Drug Application (IND) for injectable lenacapavir in HIV treatment and HIV pre-exposure prophylaxis (PrEP).
A compatibility issue regarding the container vials has prompted the agency to place the clinical hold on the use of injectable lenacapavir in borosilicate vials.
The FDA has lifted the hold after a review of the companyâs measures to rectify the issue, including the compatibility of the injection with the use of an alternative vial made from aluminosilicate glass.
After todayâs decision from the regulator, the company would work with trial site investigators to restart the lenacapavir development programs as soon as possible, Gilead (GILD) said in a statement on Monday. 
In March, Gilead (GILD) announced that the FDA declined to approve lenacapavir for the treatment of HIV infection in heavily treatment-experienced patients. The agency cited issues relating to the compatibility of the container vial as the reason for the decision.