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# SFJ Pharma BLA for Blood Thinner Reversal Agent
- URL: https://www.fdaweb.com/sfj-pharma-bla-for-blood-thinner-reversal-agent/
- Published: 2023-01-18T12:00:00.000Z
- Updated: 2026-09-14T18:12:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153559

SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals as part of a bankruptcy proceeding, and it is planning to file a BLA mid-year. Since 2020, the two companies had been co-developing bentracimab, a recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor (AstraZeneca’s blood thinner Brilinta) in patients presenting with uncontrolled bleeding or in need of surgery.

Last May, PhaseBio met with FDA and the agency agreed to accept a BLA with data from 25-30 patients with uncontrolled bleeding and data from the fully completed surgical cohort to support a label with both bleeding and surgical indications, according to a [release](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwjyoYKa9dH8AhVvjYkEHVi1CwEQxfQBKAB6BAgHEAE&url=https%3A%2F%2Fwww.businesswire.com%2Fnews%2Fhome%2F20220516005342%2Fen%2FPhaseBio-Announces-Successful-Pre-BLA-Meeting-with-U.S.-FDA-for-Bentracimab&usg=AOvVaw1YIWj5KC1OAwJPV29LeWgV) about the meeting. FDA also noted that, if during the review process the application was deemed adequate to support approval for only one indication, it would consider separating the submission for consideration under the accelerated approval pathway.