ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV (GSK) (PFE)

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced the initiation of a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.

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.1 HPTN 084 evaluated cabotegravir for HIV prevention in women who are at increased risk of HIV acquisition.2 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 (see the “About” sections below for data and safety information).

ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083.1 Breakthrough Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

“Our focus at ViiV Healthca­re is on developing innovative medicines not just to treat and cure HIV but to prevent its acquisition,” said Deborah Waterhouse, CEO of ViiV Healthcare. “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.”

“With today’s announcement we’re one step closer to being able to provide the first, long-acting, therapy to prevent HIV,” said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. “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.”

HIV continues to be a global public health crisis, with an estimated 38 million people living with HIV and 1.7 million new cases of HIV at the end of 2019.3 Advancements in research and development have identified new approaches to HIV treatment and prevention, such as cabotegravir for HIV PrEP, if approved. Long-acting cabotegravir has not been approved or licensed anywhere in the world for use in HIV prevention.

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.

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