FDA nod for first E-R, injectable regimen for adults living with HIV

The US Food and Drug Administration yesterday approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Granted to HIV specialist company ViiV Healthcare, which is majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK), this is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.

“Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission,” commented Lynn Baxter, head of North America at ViiV Healthcare.