Merck announced on March 12, 2025, its plans to begin submitting applications for marketing authorization to regulatory agencies by mid-2025 for its investigational once-daily, oral, two-drug regimen of doravirine/islatravir (DOR/ISL) for HIV-1 infection.
This follows positive data from two Phase 3 trials, MK-8591A-052 and MK-8591A-051, which showed DOR/ISL maintained HIV-1 viral suppression at Week 48. The regimen met primary efficacy and safety objectives, demonstrating non-inferiority and a similar safety profile to comparators.
The establishment of a clear regulatory timeline is a significant step towards bringing this new treatment option to market. This development reinforces Merck's commitment to addressing unmet needs in HIV treatment and diversifying its infectious disease portfolio.
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