Shots:
- The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026
- DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study
- The data from both P-III studies evaluating DOR/ISL efficacy and safety were presented at CROI’25, San Francisco
Ref: Merck | Image: Merck| Press Release
Related News:- Merck to Acquire Verona Pharma for ~$10B
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