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

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

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  • 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


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