PBR 1 2 captis executive search management consulting leadership board services

ViiV Healthcare seeks USFDA approval to expand Cabenuva use for HIV-1 infected adults

PBR 1 2 captis executive search management consulting leadership board services

Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

ViiV Healthcare seeks USFDA approval to expand use of Cabenuva to every two-month dosing. (Credit: Darwin Laganzon from Pixabay.)

Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

Cabenuva is a complete long-acting regimen to treat HIV-1 infected adults and consists of two separate injectable medicines, Janssen Sciences’ rilpivirine and ViiV Healthcare’s cabotegravir.

It helps to replace the current antiretroviral regimen in people who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen without any known or suspected resistance to either cabotegravir or rilpivirine.

The sNDA is to expand the Cabenuva’s label to include administration every two months dosing to treat HIV-1 infection in virologically suppressed adults.

Last month, the FDA has approved Cabenuva as a once-monthly, long-acting regimen for the treatment of HIV-1 infection in virologically suppressed adults.

An oral dosing of cabotegravir and rilpivirine should be administered for about one month, before initiating the treatment of Cabenuva, to assess the tolerability of each therapy.

ViiV Healthcare Research and Development head Kimberly Smith said: “Today’s submission of Cabenuva dosed every 2-months marks another meaningful step forward in our ongoing commitment to bring innovative HIV treatments to the community.

“This first-of-its-kind regimen reflects the evolving needs of people living with HIV, and, if this expanded use is approved, could allow adults living with HIV to maintain virologic suppression with six dosing days per year.

“At ViiV Healthcare, we will continue to advance new approaches to care as part of our mission of leaving no person living with HIV behind.”

The company stated that the submission of application is based on the pivotal Phase 3b ATLAS-2M (Antiretroviral Therapy as Long-Acting Suppression) study results, which showed the similar safety of taking Cabenuva every 2-months when compared to once monthly administration.

This is not a CAPTIS article. Originally, it was published here.