Janssen’s Cabenuva (rilpivirine and cabotegravir) Receives the US FDA’s Label Update Approval for the Treatment of HIV
Shots:
- The US FDA has approved a label update for Cabenuva in patients with HIV-1. The company gets an option to start OAM & q2mos. injectable regimen without the need for an oral lead-in period
- The approval was based on the P-III (FLAIR) study which showed similar outcomes regarding maintenance of virologic suppression, safety, tolerability & Pk in patients treated with cabotegravir & rilpivirine with/out the oral lead-in @124wks.
- Cabenuva is the 1st long-acting HIV treatment regimen & was approved in the US for HIV-1 in virologically suppressed adults on a stable antiretroviral regimen with no history of treatment failure & no known or suspected resistance to cabotegravir or rilpivirine
Ref: Janssen | Image: Janssen
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