Merck & Co. Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational HIV treatment, doravirine/islatravir (DOR/ISL). This once-daily, oral, two-drug regimen is designed for adults with HIV-1 infection who are virologically suppressed on antiretroviral therapy. The FDA has set a target action date of April 28, 2026, under the Prescription Drug User Fee Act. If approved, DOR/ISL would be the first FDA-approved two-drug regimen without an integrase inhibitor, offering a non-inferior efficacy and safety profile compared to current three-drug regimens. The NDA is supported by data from two Phase 3 clinical trials demonstrating its effectiveness and safety.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.