FDA Accepted BLA for the First & Only Ticagrelor Reversal Agent for Filing & Priority Review

SFJ Pharmaceuticals, (SFJ), Sponsor of the bentracimab Biologics License Application (BLA), and SERB Pharmaceuticals (SERB), who acquired exclusive US rights to bentracimab from SFJ and will commercialize bentracimab in the US, recently announced the US FDA has accepted the bentracimab BLA for filing and priority review with a target action date in Q1 of 2025.

Bentracimab is a human monoclonal antibody fragment being developed as a specific reversal agent for patients treated with ticagrelor (BRILINTA) when reversal of antiplatelet effects of ticagrelor and its active metabolite is needed in patients requiring nondeferrable surgery/invasive procedure or in patients experiencing major bleeding. In 2019, bentracimab received Breakthrough Therapy Designation from the FDA, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.

Dr. Barbara White, President and CEO of SFJ, said “Bentracimab has the potential to be an important medical advance if approved as the first and only specific reversal agent for ticagrelor, a P2Y₁₂ platelet inhibitor. We are confident that the data from the planned second interim analysis will support approval of bentracimab under priority review of the BLA.”

“Urgent medical situations can arise in patients on ticagrelor in which rapid reversal of ticagrelor’s anti-platelet effects could reduce the risk of major bleeding or facilitate hemostasis,” added Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai and Principal Investigator on the Phase 3 REVERSE-IT study. “Bentracimab has been shown in studies to reverse the anti-platelet effects of ticagrelor within 5-10 minutes after the start of its intravenous infusion.”

Vanessa Wolfeler, CEO of SERB Pharmaceuticals, also added “This milestone of BLA filing brings us closer to delivering a breakthrough therapy for patients and marks an important step in the next stage of growth for SERB. The approval of bentracimab would offer US hospitals a much-needed solution to reverse the antiplatelet effects of ticagrelor and rapidly restore platelet function when needed.”

The BLA submission is based on the planned second interim analysis results of the Phase 3 REVERSE-IT trial. The first interim analysis results of the REVERSE-IT trial were published in the New England Journal of Medicine Evidence in 2021.

Ticagrelor, marketed by AstraZeneca as BRILINTA, is P2Y₁₂ platelet inhibitor indicated: 1) to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS; 2) to reduce the risk of a first MI or stroke in patients with coronary artery disease at high risk for such events; and 3) to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack.

SFJ is a global drug development company, which provides a unique and highly customized clinical development partnering model for the world’s top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of pharmaceutical and biotechnology companies. SFJ’s mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve. www.sfj-pharma.com

SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.  https://SERB.com.