- The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir + Edurant (rilpivirine) (injected monthly) vs SOC (three-drug regimen) in 1,100+ patients infected with HIV + viral suppression across 16 countries for 48wks.
- The P-III ATLAS & FLAIR studies resulted in maintaining viral suppression period @48wks. and safety & efficacy of two-drug regime, with 85% patients preferring it over prior treatment and if approved will reduce the no. of days of treatment from 365 to 12/year
- Cabotegravir is an investigational integrase inhibitor (INI) developed by ViiV Healthcare to treat HIV. Edurant (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI). ViiV Healthcare and Janssen plans to submit a regulatory application for the combination to EMA, Health Canada in 2019
Click here to read full press release/ article | Ref: ViiV Healthcare | Image: Twitter