Dual long-acting cabotegravir/rilpivirine injection submitted to FDA

30 April 2019. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 29 April 2019, ViiV Healthcare announced that the long-acting two-drug injection formulation of cabotegravir/rilpivirine has been submitted to the US FDA. [1]

This announcement was expected following the presentation at CROI 2019 last month of the primary endpoint results from the phase 3 FLAIR and ATLAS studies. [2]

These studies reported >90% viral suppression <50 copies/mL at week-48 meeting criteria for non-inferiority compared to three-drug oral therapy.

The press release also notes that submission to the European Medicines Agency (EMA) is expected within the next few months.

References

1. ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine. (29 April 2019).
   https://www.viivhealthcare.com/en-gb/media  (direct link)
2. Collins S. Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies. HTB: 20(4), 12 March 2019.
   https://i-base.info/htb/35812