news release.“The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multidrug-resistant HIV.”Related: Carl Schmid on the “game-changer” innovations to help end HIVIn May 2019, the FDA granted Breakthrough Therapy Designation for the development of Lenacapavir for the treatment of HIV-1 infection “in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs”.In other words, because the health of these individuals is at risk because their treatment options are dwindling, the FDA gave Gilead the greenlight to speed up the development process.Subsequent.