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Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

2024-04-29

上市批准临床1期临床结果临床2期

Gilead’s Biktarvy has previously been approved by the US FDA as HIV treatment in both adult and paediatric (weighing at least 14kg) populations. Image Credit: Michael Vi / Shutterstock.

Gilead ScBiktarvyas received a US Food and Drug AdminiUS FDAon (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg).

Gilead Sciencesapproved in pregUS Food and Drug Administration (FDA)rd trimesters and up to 16 weeks followinhuman immunodeficiency virus -1 (HIV-1) viral loads of HIV-1. The FDA fiBiktarvyovbictegravir as a emtricitabinemen fortenofovir alafenamideults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.

The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of BiktFDAy in 32 pregnantBiktarvys with suppressed viral loads of HIV-1.

All FDA participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower plasma exposures observed during pregnancy compared to postpBiktarvyll 29 newborn participants had negative or nondetectable HIV-1 polymerase chain reaction (PCR) results at birth and/or at four to eight weeks postbirth.

In addition, the trial did not identify any new safety or tolerability concerns for people who use Biktarvy during pregnancy and postpartum. The overall incidence and types of adverse events observed were consistent with those expected for the population studied, as per Gilead.

See Also:Accord BioPharma’s HERCESSI secures FDA approvalBiktarvy Gilead

Biktarvy Accord BioPharmas an alternative comFDAte regimen for use in pregnancy and for people who are trying to conceive by the US Department of Health and Human Services (DHHS) perinatal guidelines.

Biktarvy is a top revenue-generating therapy in Gilead’s portfolio and pulled in $2.9bn in sales in Q1 this year, as per the company’s financials. The sales for the therapy are expected to increase to $15.5bn in 2030, as per GlobalData analysis.

Biktarvyta is the parent company of Pharmaceutical Technology.

Another HIV therapy in Gilead’s portfolio is SunGilead(lenacapavir), an FDA-approved multidrug-resistant HIV treatment. The company is evaluating Sunlenca in combination with Merck & Co’s islatravir as a long-acting HIV treatment for virologically suppressed people living with HIV.

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