ViiV Healthcare Reports Submission of MAA to EMA for the Combination of Cabotegravir + Rilpivirine to Treat HIV-1 Infection

 ViiV Healthcare Reports Submission of MAA to EMA for the Combination of Cabotegravir + Rilpivirine to Treat HIV-1 Infection

ViiV Healthcare Reports Submission of MAA to EMA for the Combination of Cabotegravir + Rilpivirine to Treat HIV-1 Infection

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

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

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