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European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations
– EC Authorizes a Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children at Least Two Years of Age and Weighing at Least 14 kg, Helping to
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– EC Authorizes a Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children at Least Two Years of Age and Weighing at Least 14 kg, Helping to Address a Critical Unmet Need –\n\n– Biktarvy Provides an Effective Therapy Choice for a Diverse Range of People Living with HIV, including Children with Limited Treatment Options –\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has authorized a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.\n\n“The European Commission’s approval is a significant milestone to address what is sadly an important unmet need, namely children with HIV requiring new treatment options,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic. Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in pediatric HIV research.”\n\nWhile there have been many advances in the treatment of HIV in children and adolescents, there remains a need to prioritize, evaluate and develop options for the millions of the children worldwide. In 2021, an estimated 800,000 children under the age of 19 living with HIV were still not receiving HIV treatment. Children comprised 4% of people with HIV in 2021 but 15% of AIDS-related deaths, and the gap in HIV treatment coverage between children and adults is increasing rather than narrowing.\n\nThe authorization of an extended indication and line extension for Biktarvy for the treatment of HIV in children at least two years of age and weighing at least 14 kg is based on an open-label study (NCT02881320), which found Biktarvy to be effective and generally well-toler...