Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

KEY FACTS:

• Regulatory submission is based on positive results from the Phase III OCEANIC-STROKE study
• OCEANIC-STROKE met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer:

WHAT’S HAPPENING

Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OCEANIC-STROKE trial. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine.

BAYER EXECUTIVE COMMENT

“Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention,” said Yesmean Wahdan, M.D., Senior Vice President, U.S. Medical Affairs, Bayer. “We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.”

In 2023, asundexian was granted Fast Track Designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The FDA has now granted Priority Review for asundexian, a designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.¹

WHY THIS MATTERS

Stroke is the fifth leading cause of death in the United States.² Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.³ Despite current guideline recommendations for stroke prevention, a significant proportion of survivors experience another stroke.^4,5 Approximately one in five stroke survivors will have another stroke within five years.⁵

About FXIa
Factor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage.

About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat such diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at: Health for all, Hunger for none | Bayer United States
Follow us on Facebook: Bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals
Follow us on X: BayerUS
Follow us on Instagram: bayerofficial

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1. U.S. Food and Drug Administration. “Priority Review.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
2. Martin SS, et al. Circulation. 2024;149(8):e347–e913.
3. Virani SS, et al. Circulation. 2021;143:e254–e743
4. Kolmos M, et al. J Stroke Cerebrovasc Dis. 2021;30(8):105935.
5. Lakshminarayan K, et al. Stroke. 2011;42(6):1556–1562.