BRIEF—EC expands indication for Gilead's Biktarvy

The European Commission (EC) has authorized a new low-dose tablet dosage form of Gilead Sciences’ Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg 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.

“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 Dr Jared Baeten, 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,” Dr Baeten added.