Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation

05/25/2023

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway

Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen), today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor, have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexiadevelopment program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical development program to date and will provide extensive 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,” said Robert Harrington, MD, Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine, Stanford University, Librexia program chair.i “If successful, milvexian could open the door to treat an entirely new set of patients who are currently overlooked due to bleeding risk.”

All three indications being studied in the Phase 3 Librexia program were granted Fast Track Designation from the FDA. Fast Track Designation is intended to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical need for serious or life-threatening conditions. Fast Track Designation encourages close communication between the FDA and sponsor to improve the efficiency of product development, with the aim of getting new therapeutics to patients faster.

“This Fast Track Designation underscores the unmet need that exists in the treatment of thromboembolic conditions,” said Puneet Mohan, MBBS, MD, PhD, vice president, Global Program Lead, Milvexian, Bristol Myers Squibb. “The goal of milvexian and the Librexiaprogram 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.”

Phase 2 AXIOMATIC-TKR and AXIOMATIC-SSP proof-of-concept data for milvexian demonstrated a differentiated antithrombotic profile as both a monotherapy and in combination with antiplatelet therapy. These data also suggest a positive efficacy and bleeding profile in stroke patients where FXa inhibitors are not indicated.

About Milvexian*

Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program, the most comprehensive FXIa clinical development program to date.

*Milvexian is an investigational agent and has not been approved for use in any country, for any indication.

About the Librexia Program

The Librexia program is unrivaled as the most comprehensive FXIa clinical development program to date, studying nearly 50,000 patients across three parallel clinical trials (Librexia STROKE, Librexia ACS and Librexia AF). Grounded in positive Phase 2 efficacy and safety data, the Librexia program aims to investigate whether milvexian can enhance the benefit-risk profile associated with treating patients with these three conditions by delivering reduced thrombotic events with no increased risk of bleeding. The program is designed to potentially advance beyond the standard of care and help improve outcomes in a wide range of patients with thrombotic diseases. Each indication under evaluation in the Librexia program has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). Librexia STROKE, Librexia ACS and Librexia AF are dosing patients.

About Librexia STROKE

Librexia STROKE is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of milvexian in addition to single or dual antiplatelet therapy for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack (TIA). More information can be found on http://www.clinicaltrials.gov (NCT05702034).

About Librexia ACS

Librexia ACS is a randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian after a recent acute coronary syndrome. More information can be found on http://www.clinicaltrials.gov (NCT05754957).

AboutLibrexia AF

Librexia AF is a randomized, double-blind, double-dummy, parallel group, active-controlled study to evaluate the efficacy and safety of milvexian versus apixaban in participants with atrial fibrillation. More information can be found on http://www.clinicaltrials.gov (NCT05757869).

About the Bristol Myers Squibb/Janssen Collaboration

Bristol Myers Squibb and the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen),two unsurpassed leaders in cardiovascular care, are determined to close the gap in unmet needs in thrombosis management by overcoming the limits of today’s treatments. The collaboration to develop and commercialize milvexian aims to leverage the combined scientific heritage and world-class commercial capabilities of each company, all in service of improved patient outcomes. The alliance is uniquely equipped to deliver on the promise of FXIa inhibitors and is working diligently to ensure cutting-edge safe and effective treatment options are available for patients.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that milvexian may not achieve its primary study endpoints or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

i Dr. Harrington is affiliated with Stanford University, and was provided payment for his participation in the Phase 3 Librexia program.

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