Merck announces that the US FDA has agreed to review the New Drug Application (NDA) for DOR/ISL, an experimental oral, once-daily, two-drug treatment for adults living with HIV-1 whose viral load is already controlled with antiretroviral therapy.
The agency has set April 28, 2026, as the target date for making a decision on this application.
This NDA is based on 48-week results from two pivotal Phase 3 studies.
In a first study, DOR/ISL demonstrated similar efficacy to the antiretroviral therapy regimen that patients were taking prior to the study, with no loss of virologic control. In a second double-blind study, it was also shown to be as effective as the standard combination BIC/FTC/TAF, confirming that it is not inferior in terms of viral suppression.
Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, emphasizes that this treatment, if approved, "will represent an important comprehensive option to meet the diverse needs of people living with HIV."
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Merck & Co., Inc. specializes in the development, production, and marketing of therapeutic products and vaccines sold under prescription. Net sales break down by activity as follows:
- sale of pharmaceutical products (69.4%): for treating hypertension, osteoporosis, atherosclerosis, respiratory, bacterial and fungal, ophthalmologic, and urological diseases, acute migraine, hair loss in men, etc.;
- sale of vaccines (20%);
- sale of animal health products (9.2%);
- other (1.4%).
Net sales are distributed geographically as follows: the United States (50.3%), Europe/Middle East/Africa (21.8%), Latin America (5.4%), China (8.6%), Japan (5.1%), Asia/Pacific (4.8%) and other (4%).
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