Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

Gilead Sciences has resubmitted a New Drug Application (NDA) for its investigational drug lenacapavir following the Complete Response Letter the company received from the FDA in February.

The FDA declined to approve the NDA in February because of problems with the incompatibility of the borosilicate vials for the product. The resubmission includes new data on the use of vials made of aluminosilicate glass.

Gilead is seeking approval of the long-acting human immunodeficiency virus (HIV)-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection.