New HIV prevention drug application submitted to FDA
pharmafile | May 5, 2021 | News story | Research and Development | FDA, HIV
ViiV Healthcare have initiated a rolling submission of a new drug application (NDA) with the FDA for their long-acting HIV prevention drug, cabotegravir.
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.
Cabotegravir is a long-acting injectable administered every eight weeks, designed for the prevention of HIV acquisition, also known as pre-exposure prophylaxis, or PrEP.
The NDA is based upon results from two phase IIb/III studies, HPTN 083 and HPTN 084, which looked at the safety and efficacy cabotegravir for HIV prevention in men who have sex with men and transgender women, and also in women who are at increased risk of HIV acquisition.
Both studies were stopped early by the Data Safety Monitoring Board, after finding cabotegravir to be superior to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “Our focus at ViiV Healthcare is on developing innovative medicines not just to treat and cure HIV but to prevent its acquisition.
“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 is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer, with Shionogi joining the company in October 2012.
ViiV Healthcare was granted Breakthrough Therapy Designation by the FDA for long-acting cabotegravir in November 2020, based on efficacy and safety results from HPTN 083.
The company 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.
Kimberly Smith, MD, MPH, Head of Research and Development at ViiV Healthcare, said: “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 FTC/TDF.
“With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill. If approved, cabotegravir would play a role in expanding the PrEP landscape in the US, particularly for those who are most vulnerable to acquiring HIV.”
An estimated 38 million people currently live with HIV with 1.7 million new cases of HIV reported at the end of 2019.
Kat Jenkins
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