Gilead Says FDA Approves Expanded Indication of Biktarvy for Treatment of HIV-1 in Pediatric Populations

By Michael Dabaie

Gilead Sciences Inc. said the U.S. Food and Drug Administration approved an expanded indication of its Biktarvy for treatment of HIV-1 in pediatric populations.

Gilead said the FDA approved a new low-dose tablet dosage form of Biktarvy for pediatric patients weighing at least 14 kilograms to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

The approval expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children, the company said.

The new approval of Biktarvy is based on data from cohort three of a Phase 2/3 open-label, single-arm study which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1.

"Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy," said Chief Medical Officer Merdad Parsey. "To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children."

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

October 18, 2021 08:07 ET (12:07 GMT)

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