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 United States, announced today that the US Food and Drug Administration (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,“ said 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, said “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.
