Shots:

• The MAA is based on P-III ATLAS and FLAIR studies results assessing cabotegravir + rilpivirine (monthly injectable) in 1-100+ patients with HIV-1 infection with suppressed viral load who are not resistant to cabotegravir or rilpivirine demonstrated similar efficacy to 3-drug oral regimen
• The EMA’s MAA follows NDA submission of dual regimen to the US FDA in Apr’2019 and has received FDA’s PR designation with its anticipated PDUFA date as Dec 29- 2019. The ViiV and Janssen plans to submit other regulatory applications in Aug’19
• Janssen’s rilpivirine (marketed as Edurant) is a NNRTI inhibitor- used with other ARV to treat HIV-1 infection in patients aged ≥12yrs. GSK’s cabotegravir is an integrase inhibitor with a carbamoyl pyridone structure similar to dolutegravir and is under development to treat HIV infection

Click here to­ read full press release/ article | Ref: GSK | Image: Twitter