LFB S.A. Gains FDA CBER Approval for SEVENFACT in Hemophilia A and B with Inhibitors

Regulatory affairs teams benchmarking recombinant coagulation factor biologics now have an updated CBER reference point: LFB S.A.'s coagulation factor VIIa (recombinant)-jncw, marketed as SEVENFACT, carries a labeling supplement approval dated June 20, 2024, the most recent in a documented approval history extending back to April 2020.

SEVENFACT holds a Biologics License (BL 125641) for the treatment and control of bleeding episodes in adults and adolescents aged 12 and older with hemophilia A or B with inhibitors. The product's regulatory file includes the original April 1, 2020 approval, a subsequent November 22, 2022 approval letter, and the June 2024 labeling supplement, each accompanied by clinical review memos and, for the original approval, a statistical review and Summary Basis for Regulatory Action.

For regulatory affairs leads tracking labeling supplement trends at CBER, the June 2024 action is particularly relevant. Labeling supplements for recombinant biologics require documented clinical review under 21 CFR Part 601, and the publicly available Clinical Review Memo of Labeling Supplement provides a compliance benchmarking reference for teams managing comparable recombinant factor products through post-approval lifecycle changes.

The full supporting document package, including the current Package Insert and Patient Product Information, is accessible via the FDA CBER product page, offering a consolidated view of the product's regulatory history across three distinct approval actions over four years.

Teams managing post-approval biologics submissions can use the SEVENFACT dossier structure, particularly the layered approval letters and accompanying clinical review documentation, as a reference framework when preparing labeling supplements for recombinant coagulation factor programs under CBER jurisdiction.

Source: FDA CBER via What's New Vaccines Blood Biologics RSS Feed, June 1, 2026.