ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay
ViiV Healthcare press release
London, 22 June 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) to extend the use of Tivicay PD (dolutegravir (DTG)) to newborns from birth. The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 25, 2026.
The European Medicines Agency (EMA) has also validated the marketing application for Tivicay, as the company continues to focus on addressing one of the most persistent gaps in care by expanding age-appropriate treatment options for the earliest stage of life.
Read the full press release here.
Source : ViiV Healthcare
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