ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to the US FDA to Treat HIV-1 Infection in Adults

 ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to the US  FDA to Treat HIV-1 Infection in Adults

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to the US FDA to Treat HIV-1 Infection in Adults

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post