FDA Gives Fast-Track Tag To Merck’s Latest Anticoagulant

Merck has been granted a rare gift in the medical product approval process: the FDA has put a fast-track tag on its newest anticoagulant solution, a midphase asset XI/Xla inhibitor leveraging molecule MK-2060. The benediction will help Merck bring a standard-of-care anticoagulation therapy for end-stage renal disease (ESRD) patients to market in an accelerated timeline. The fast-track tag certifies use of MK-2060 to mitigate the significant thrombotic events common among ESRD patients.

The dual-factor XI/Xla inhibitor in play here has been fleshed out to address the needs of higher-risk ESRD patients; the lack of a top-shelf drug to help prevent blood clots in patients with higher bleeding risks will make Merck’s MK-2060 solution a godsend for providers. The prospective success rate of its clinical use is buoyed by research showing that patients with inherited factor XI deficiency carry a lower risk of thrombotic events with an increased risk of major bleeding.

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Anticoagulation through factor XI is nothing new to the sector, and several other companies have tapped into it. Anthos Therapeutics, a Novartis offshoot, has its phase-three Abelacimab antibody, which like MK-2060 is able to inhibit both Xl and Xla. That program, however, is meant for treatment in cancer-related venous thromboembolism. Merck’s other competition in this endeavor includes Bayer, which is toying with a factor Xl antisense candidate, and Aronora, which beyond an adjacent collaboration with Bayer has brought forward phase-2 ESRD data on factor Xl candidate AB023.