FDA Approves ViiV Healthcare's Cabenuva For Virologically Suppressed Adolescents With HIV

The FDA has approved ViiV Healthcare's Cabenuva (cabotegravir, rilpivirine) for HIV-1 in virologically suppressed adolescents.
The approval covers patients aged 12 years or older and weighing at least 35kg on a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.
The regimen was co-developed in collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson JNJ.
This approval marks the first time a long-acting HIV treatment is available for adolescents.
Related: FDA Approves First Injectable For HIV Pre-Exposure Prevention - GSK, Pfizer Backed Treatment.
ViiV Healthcare is majority-owned by GlaxoSmithKline plc GSK, Pfizer Inc PFE, and Shionogi Limited.
Cabenuva is the first and only complete long-acting HIV treatment regimen. It is approved as a once-monthly or every-two-months treatment.
The expanded indication for Cabenuva is supported by studies in adults and data from the Week 16 interim analysis of the ongoing MOCHA study.
Price Action: GSK stock is down 0.59% at $43.12, PFE shares are down 0.76% at $52.88 during the market session on the last check Tuesday.

Overview Rating:

Speculative

0100