The BLA submission is grounded on the second interim analysis results of the Phase III REVERSE-IT trial. Credit: Michal Jarmoluk from Pixabay.

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of SFJ Pharmaceuticals and SERB Pharmaceuticals’ bentracimab for filing and priority review.

A human monoclonal antibody fragment, bentracimab is being developed as a reversal agent for ticagrelor, a medication used to reduce the risk of stroke or heart attack.

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SFJ Pharmaceuticals, sponsor of the bentracimab BLA, has partnered with SERB Pharmaceuticals, which has acquired exclusive US rights to the asset.

SERB Pharmaceuticals is set to commercialise bentracimab in the US market, subject to approval.

The FDA decision on the approval of bentracimab is anticipated in the first quarter (Q1) of 2025.

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The BLA submission for bentracimab is grounded on the second interim analysis results of the Phase III REVERSE-IT trial. The first interim analysis of this trial was published in 2021.

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SFJ president and CEO Dr Barbara White stated: “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.”

Bentracimab is designed to counteract the antiplatelet effects of ticagrelor and its active metabolite in situations where reversal is necessary, such as nondeferrable surgery or invasive procedures, or in cases of major bleeding.

SERB Pharmaceuticals CEO Vanessa Wolfeler 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 product received breakthrough therapy designation from the FDA in 2019, which accelerates the development and review process for treatments that show potential for significant improvement over existing therapies.