FDA Grants Priority Review to SFJ and SERB's Bentracimab BLA

The US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for bentracimab, developed by SFJ Pharmaceuticals and SERB Pharmaceuticals, for priority review. Bentracimab is a human monoclonal antibody fragment designed to counteract the effects of ticagrelor, a medication commonly used to lower the risk of stroke or heart attack. The application was submitted based on the second interim analysis results of the Phase III REVERSE-IT trial, following the first interim analysis published in 2021.

SFJ Pharmaceuticals serves as the sponsor of the bentracimab BLA, while SERB Pharmaceuticals has secured exclusive rights to market the drug within the United States. The FDA is expected to make a decision on the approval of bentracimab in the first quarter of 2025. If approved, SERB Pharmaceuticals plans to commercialize the drug in the US market.

Dr. Barbara White, president and CEO of SFJ Pharmaceuticals, expressed confidence in bentracimab's potential to become the first and only specific reversal agent for ticagrelor, a P2Y12 platelet inhibitor. She believes that the data from the second interim analysis will be robust enough to support the drug's approval under the FDA's priority review process.

Bentracimab has been specifically designed to neutralize the antiplatelet effects of ticagrelor and its active metabolite. This is particularly crucial in situations where rapid reversal is needed, such as non-deferrable surgeries, invasive procedures, or major bleeding events. The drug aims to provide a much-needed solution to quickly restore platelet function when necessary.

Vanessa Wolfeler, CEO of SERB Pharmaceuticals, highlighted the significance of this milestone, stating that the BLA filing marks an essential step towards delivering an innovative therapy for patients. She emphasized that the approval of bentracimab would provide US hospitals with a critical tool to reverse ticagrelor's antiplatelet effects and swiftly restore normal platelet function.

In 2019, bentracimab received breakthrough therapy designation from the FDA. This designation is reserved for treatments that offer substantial improvement over existing therapies, and it accelerates the development and review processes for such drugs. The breakthrough therapy designation underscores the potential impact of bentracimab in addressing an unmet medical need.

In summary, the acceptance of the BLA for bentracimab by the FDA marks a significant step forward for SFJ Pharmaceuticals and SERB Pharmaceuticals. With the anticipated decision in early 2025, the drug holds promise for becoming a critical medical advance, offering a specific reversal agent for ticagrelor and addressing urgent medical situations that require rapid restoration of platelet function. The ongoing developments in the REVERSE-IT trial and the support from breakthrough therapy designation further solidify bentracimab's potential to make a meaningful difference in patient care.