ViiV Healthcare Reports Regulatory Submission to the US FDA and EMA for Dispersible Formulation of Tivicay (dolutegravir)

Shots:

• The company has filed submissions to both EMA and FDA for the approval of the first-ever DT formulation of DTG (5mg) as well as a simplified dosing regimen to optimize the use of the existing DTG (50mg, FCT) in pediatric patients with HIV
• The regulatory submission to the FDA and EMA is based on an ongoing P1093 study evaluating safety, tolerability & antiviral activity of DTG regimens and ODYSSEY (PENTA20) study assessing DTG as 1L/ 2L therapy vs SOC in children aged 4wks. to 18yrs., conducted in collaboration with IMPAACT and PENTA network respectively
• Following the approval, DT formulation of DTG will be the first INST inhibitor available as a dispersible tablet for pediatric patients with HIV thus closing the gap b/w treatment options available for adults and children

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