Global biopharmaceutical company Bristol-Myers Squibb announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to BMS-663068 in combination with other antiretroviral agents for the treatment of HIV-1 infection in heavily treatment-experienced patients.  Heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable three-drug treatment regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications.  BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor, in comparison to the current entry inhibitors, is designed 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 BTD is based on promising data from the Phase IIb clinical trial presented earlier this year and recognizes the unmet medical need for novel therapies for HIV patients who become resistant to current therapies.


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