Gilead Says FDA Approves Expanded Indication of Biktarvy for Treatment of HIV-1 in Pediatric Populations
October 18 2021 - 7:22AM
Dow Jones News
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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