FDA approves MSD’s once-daily HIV combo Idvynso
FDA approves MSD’s once-daily HIV combo Idvynso
Publish Date: 2026-04-22 07:15:00
Source Domain: www.pharmaceutical-technology.com
Idvynso is the first non-INSTI, tenofovir-free, two-drug regimen to get the FDA’s blessing. Credit: Tatyana Frolova / Shutterstock.com.
MSD (Merck & Co) has secured a US approval for its two-drug human immunodeficiency virus (HIV) combination therapy, Idvynso (doravirine/islatravir), as the company looks to secure a slice of the lucrative market.
Once-daily Idvynso was given the US regulatory greenlight based on the results of the Phase III MK-8591A-051 and MK-8591A-052 (NCT05631093; NCT05630755) trials, which found that patients switched from Gilead’s SoC therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), maintained viral suppression at a non-inferior level when taking Idvynso daily.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Find out more
This means that American patients who are virologically suppressed and on a stable antiretroviral (ART) regimen can now be switched to Idvynso, provided they have not previously experienced virologic treatment failure or doravirine resistance.
According to Anaelle Tannen, infectious disease analyst at GlobalData, Idvynso’s regulatory greenlight reflects a broader shift in the HIV treatment landscape away from traditional three-drug combinations toward simpler, potentially more tolerated options.
Currently, the HIV market is dominated by Gilead’s three-drug regimen, Biktarvy, though GSK’s dual therapy, Dovato…
