FDA designates long-acting PrEP a breakthrough therapy
The FDA has granted breakthrough therapy designation status to long-acting, injectable cabotegravir for HIV PrEP, according to ViiV Healthcare.
The updated designation is based on results from the HIV Prevention Trials Network 083 study (HPTN 083), which showed that transgender women and men who have sex with men who were taking injectable cabotegravir were 66% less likely to acquire HIV than those taking daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
ViiV released data recently from the HPTN 084 study that showed long-acting cabotegravir was also more effective than FTC/TDF among cisgender women. ViiV said it would use the data from both studies for future regulatory submissions.
“New medicines that decrease the risk of HIV acquisition in at-risk populations are an essential tool to help us end the global HIV epidemic,” Kimberly Smith, MD, MPH, head of research & development at ViiV Healthcare, said in a press release. “Our data from the HPTN 083 and 084 studies show that long-acting cabotegravir is superior to daily oral FTC/TDF tablets for HIV prevention.”
The breakthrough therapy designation will allow ViiV to work with the FDA to expedite both the drug’s development and data collection for information needed to reach approval.