Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BMS-663068, when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.

The Breakthrough Therapy designation is based on data from the Phase 2b clinical study comparing BMS-663068 to Reyataz (atazanavir sulfate) plus ritonavir in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate. A Phase 3 trial in heavily treatment-experienced patients began in February 2015 and is ongoing.

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BMS-663068 is a first-in-class HIV-1 attachment inhibitor designed to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus block its entry into the cell.

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