ViiV announces rolling submission of NDA for long-acting injectable PrEP
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ViiV Healthcare said Tuesday that it has initiated a rolling submission of a new drug application for long-acting injectable cabotegravir for HIV PrEP.
The rolling submission will allow ViiV to submit portions of the application to the FDA as they are finished rather than waiting until all of the NDA is completed, the company noted.
“With today’s announcement, we’re one step closer to being able to provide the first, long-acting, therapy to prevent HIV,” Kimberly Smith, MD, MPH, ViiV’s head of research and development, said in a press release. “This is the kind of innovative option for prevention that the field has been asking for, and is supported with efficacy and safety data of cabotegravir compared to daily, oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).”
ViiV said its rolling submission is based on results from the HIV Prevention Trials Network 083 and 084 studies.
Findings from HPTN 083 showed that injectable cabotegravir given every 8 weeks offered superior protection against HIV infection compared with daily oral FTC/TDF. Results from HPTN 084 demonstrated that bimonthly injectable cabotegravir was 89% more effective than oral FTC/TDF for HIV prevention in cisgender women.
Experts have said that the added protection provided by long-acting cabotegravir is likely a result of participants in the daily oral PrEP arms of the two studies not always taking the medication as prescribed.
Data from HPTN 083 also showed that cabotegravir delayed the detection of some incident HIV infections using standard HIV testing.
In November, the FDA designated long-acting injectable cabotegravir as a breakthrough therapy.
ViiV said it will begin submitting files by the end of 2021 and will focus its submissions on countries in which the HPTN 083 and 084 studies were conducted.
“With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill,” Smith said in the release. “If approved, cabotegravir would play a role in expanding the PrEP landscape in the United States, particularly for those who are most vulnerable to acquiring HIV.”
Perspective
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This is yet another exciting step toward improving compliance with PrEP — with ease of use, coupled with decreased frequency of dosing (compared with daily dosing). We know that PrEP is good only as long as it’s taken — and as we inch toward the possible approval of the first, long-acting therapy for HIV PrEP, may the force be with us!
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