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Merck wins Fast Track designation from FDA for experimental anticoagulant therapy

By Brian Buntz | August 23, 2022

Merck in the Drug Discovery & Development Pharma 50FDA has informed Merck (NYSE:MRK) that its investigational anticoagulant therapy MK-2060 has received Fast Track designation. The program accelerates the review of new drugs to treat serious conditions or unmet medical need.

The Fast Track designation covers the risk reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

“We are encouraged by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a news release. “Today, there is no anticoagulation standard of care for such patients.”

A Phase 2 Study of MK-2060 is now underway in people with end-stage renal disease who are undergoing hemodialysis.

The FXI hemodialysis study will test two different doses of the investigational anticoagulant therapy MK-2060. In addition, Merck will use data from the study to inform the dose selection of MK-2060 in future trials.

MK-2060 is an intravenously delivered factor XI inhibitor. The monoclonal antibody is also designed to activate downstream proteins involved in the blood coagulation cascade.

A handful of other companies are developing novel anticoagulation drug candidates, including Anthos Therapeutics, whose abelacimab antibody is in a Phase 3 study.

MRK shares were down about 1% to $90.20.

The company’s shares reached a 52-week high of $95.72 on June 27.

Last week, Merck announced a deal with Orna Therapeutics, which specializes in engineered circular RNA (oRNA) therapies. Creating oRNA involves modifying mRNA strands to form circles instead of lines.

Under the terms of that partnership, Merck will make an upfront payment of $150 million to Orna. In addition, the company could pay up to $3.5 billion in additional milestone-based payments.

Merck is also reportedly mulling the acquisition of Seagen (Nasdaq:SGEN).


Filed Under: Hematology
Tagged With: anticoagulant therapy, fast track designation, FDA, Merck
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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