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Gilead's (GILD) Biktarvy Gets FDA Nod for Pediatric Patients

Gilead Sciences, Inc. GILD recently announced the FDA has approved a supplemental new drug application (sNDA) for flagship HIV therapy Biktarvy. 

The regulatory body approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

The approval of Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of phase II/III open-label, single-arm study. Data from the study showed that Biktarvy low-dose tablets were effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing ≥14 to <25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase.

Pediatric HIV remains a crucial health problem despite effective available treatment options for pregnant women living with HIV lowering the likelihood of perinatal HIV infection transmission.

The FDA approved Biktarvy as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults in 2018. Thereafter, in June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg.

Label expansion of the treatment will boost sales of the same, which came in at $3.8 billion in the first half of 2021.

Gilead’s stock has gained 16.7% this year against the industry's decline of 10.5%.

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Gilead is looking to strengthen its HIV franchise, which was adversely impacted by the ongoing pandemic and the loss of exclusivity of Truvada and Atripla. Competition is stiff as well from the likes of GlaxoSmithKline GSK.  Gilead has collaborated with a subsidiary of Merck MRK to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.

The massive decline in its HCV business has forced Gilead to focus on its HIV franchise and diversify into the oncology space, which promises potential despite stiff competition.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Regeneron Pharmaceuticals REGN which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised upward by 3.3% for 2021 and 0.3% for 2022 over the past 30 days. The stock has jumped 13.6% year to date.


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