Milvexian granted fast track designation for prevention of thrombotic events
Click Here to Manage Email Alerts
Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals announced all three prospective antithrombotic indications for milvexian have received fast track designation from the FDA.
The designation covers all three phase 3 Librexia development studies of the investigational oral factor XIa inhibitor: Librexia Stroke, Librexia ACS and Librexia AF. According to a company press release, the program is intended to provide data from nearly 50,000 patients.
“Despite major advances in cardiovascular and stroke treatment over the past two decades, millions of patients currently remain untreated or undertreated due to the risk of bleeding, but for whom thrombotic events could be prevented,” Robert Harrington, MD, Arthur L. Bloomfield professor of medicine and chair of the department of medicine at Stanford University, said in the release. “If successful, milvexian could open the door to treat an entirely new set of patients who are currently overlooked due to bleeding risk.”
Milvexian was previously evaluated in the phase 2 AXIOMATIC-TKR trial that enrolled 1,242 patients scheduled for knee arthroplasty and assigned to one of seven oral milvexian regimens compared with once-daily subcutaneous enoxaparin after the procedure.
As Healio previously reported, oral milvexian was effective at preventing venous thromboembolism and demonstrated a low rate of bleeding.
The drug was also studied in the phase 2 AXIOMATIC-SSP trial, for which researchers tested the dose-response relationship of milvexian for the secondary prevention of stroke, with the primary outcome of symptomatic ischemic stroke and covert brain infarction.
The researchers reported that milvexian was protective against ischemic stroke and did not increase risk for intracranial hemorrhage compared with placebo for secondary stroke prevention.
“This fast track designation underscores the unmet need that exists in the treatment of thromboembolic conditions,” Puneet Mohan, MBBS, MD, PhD, vice president and global program lead for milvexian at Bristol Myers Squibb, said in the release. “The goal of milvexian and the Librexia program is to enhance the benefit-risk profile in the treatment of these conditions by delivering reduced thrombotic events and less bleeding in at-risk patients than the current standard of care.”
The fast track designation is granted to therapies with the potential to fill unmet needs of patients with serious medical conditions. It includes the ability for the developer to have more frequent interactions with the agency, and potentially future accelerated priority review and accelerated approval.
Collapse
Read more about
Click Here to Manage Email Alerts