US FDA Lifts Clinical Hold On Gilead’s Lenacapavir HIV Treatment


Gilead Sciences, Inc. announced that, the Food and Drug Administration (FDA) of the United States has lifted the clinical hold, which was place on the Investigational New Drug (IND) Application of the company for the purpose of evaluating the injectable lenacapavir for the treatment of HIV and HIV pre-exposure prophylaxis (PrEP).

As announced in the past, the US FDA had placed a clinical compatibility issue and the US FDA has also removed the clinical hold followed by the review from US FDA of the comprehensive plan of Gilead and corresponding data on the storage and compatibility of the lenacapavir injection along with alternative dose made from the aluminosilicate glass.

Followed by the decision from the US FDA, all the activities can possibly resume in the clinical studies evaluating the injectable lenacapavir for the HIV treatment and HIV PrEP and the at the time of the clinical hold, the screening and enrolment of the study particpants and the dosing of the injectable lenacapavir had not been permitted across all the studies of lenacapavir.

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Merdad Parsey, chief medical officer at Gilead Sciences said, they are very happy for having identified as an alternative vial for the lenacapavir and to advance in the robust clinical program for the potential and first in calls and long-acting option for the prevention and treatment of HIV.