“We are now 30-plus years into the AIDS epidemic, and there is an ever-increasing number of long-term survivors of the condition, many of whom are facing issues of drug resistance and are in need of new treatment options,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “The Breakthrough Designation recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients, and is evidence of Bristol-Myers Squibb’s continued focus on meeting that need.”
Breakthrough Therapy Designation expedites the development and review of new therapies meant to treat serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Designation for BMS-663068 is a significant milestone and will help speed development of the investigational compound for heavily treatment-experienced patients.
About Bristol-Myers Squibb in HIV
For more than 20 years, Bristol-Myers Squibb has focused on delivering innovative medicines to help meet the needs of patients living with HIV-1. Our goal is to help individuals living with HIV-1 to live longer and healthier lives by achieving and maintaining viral suppression, and by managing challenges associated with treatment resistance. We are investigating new ways to attack the HIV virus, and studies are ongoing for innovative treatments including the HIV-1 attachment inhibitor (BMS-663068) and an HIV-1 maturation inhibitor (BMS-955176).