U.S. FDA accepts NDA for Merck’s doravirine islatravir

U.S. FDA accepts NDA for Merck’s doravirine islatravir

The U.S. Food and Drug Administration (FDA) has accepted Merck's New Drug Application (NDA) for doravirine islatravir, a novel combination therapy for HIV treatment. This approval marks a significant milestone in Merck's HIV clinical development pipeline, following the presentation of new data at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda [1].

Merck's doravirine islatravir combination is a once-weekly oral regimen designed to treat adults with HIV-1 infection. The therapy aims to simplify HIV treatment by reducing the frequency of dosing, potentially improving patient adherence and quality of life. The FDA's acceptance of the NDA is based on the positive results from two Phase 1 and one Phase 2b clinical trials, which demonstrated the safety and tolerability of the drug combination [1].

The data presented at IAS 2025 included findings from a Phase 2b dose-ranging study that evaluated a higher dose of islatravir (20mg) and three doses of ulonivirine in treatment-naive adults living with HIV-1. These trials also assessed the safety and tolerability of weekly dosing of ulonivirine and drug interactions between islatravir and ulonivirine [1].

Merck has been actively developing this combination therapy, with the goal of providing an effective and convenient treatment option for HIV patients. The company has been conducting extensive research on the pharmacokinetics and safety profiles of doravirine and islatravir, with a focus on minimizing side effects and improving patient outcomes.

The FDA's acceptance of the NDA is a significant step forward in the fight against HIV. It is expected that doravirine islatravir will become available in the market soon, providing healthcare providers with a new tool to manage HIV infections more effectively.

References:
[1] https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/Merck-to-Present-New-Data-Highlighting-Research-Advancements-Across-its-HIV-Prevention-and-Treatment-50457482/