FDA grants Bristol-Myers Squibb Breakthrough Therapy designation for HIV compound

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational compound BMS-663068 from Bristol-Myers Squibb (NYSE: BMY).

The designation has been granted when the compound is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.

The FDA granted this designation based on data from the Phase IIb clinical study comparing BMS-663068 to a boosted protease inhibitor (atazanavir sulfate and ritonavir) in treatment-experienced patients, with treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate.