ViiV Healthcare initiates rolling submission of new drug application with FDA for long-acting cabotegravir for 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.
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