ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir (pre-exposure prophylaxis, or PrEP) for the prevention of HIV.
The rolling submission allows ViiV Healthcare to submit portions of the regulatory application to the FDA as they are completed, rather than waiting until every section of the NDA is complete to submit the entire application for review.
The complete submission will be based on results from two phase IIb/III studies, HPTN 083 and HPTN 084. HPTN 083 evaluated the safety and efficacy of long-acting cabotegravir for HIV prevention in men who have sex with men and transgender women.
HPTN 084 evaluated cabotegravir for HIV prevention in women who are at increased risk of HIV acquisition.
The Data Safety Monitoring Board stopped the blinded, randomised portion of both studies early after cabotegravir was shown to be superior to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets.
ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “Today’s announcement marks a critical milestone in our efforts to create a new PrEP option that provides an alternative to the need to take a pill every day. We believe this is a major step towards ending the epidemic.”
ViiV Healthcare plans to start submission of regulatory files with global regulatory authorities by the end of this year and will initially focus submissions on countries where the HPTN 083 and HPTN 084 clinical trials were conducted.