Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data [Yahoo! Finance]
Merck & Company, Inc. (new) (MRK)
Last merck & company, inc. (new) earnings: 4/28 06:45 am
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Source: Yahoo! Finance
combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults 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 Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower plasma exposures observed during pregnancy compared to postpartum. All 29 newborn participants had negative or nondetectable HI
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Earnings
- 4/25/24 - Beat
MRK
Sec Filings
- 5/15/24 - Form 424B5
- 5/15/24 - Form POSASR
- 5/6/24 - Form 144
- MRK's page on the SEC website