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# Bio Products sBLA Accepted for Coagadex
- URL: https://www.fdaweb.com/bio-products-sbla-accepted-for-coagadex/
- Published: 2018-05-25T12:00:00.000Z
- Updated: 2026-09-15T00:07:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141541

FDA has accepted for review a Bio Products Laboratory supplemental BLA for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary factor X deficiency. The submission is based on data from TEN02, a Phase 3 prospective study. The primary endpoint was the investigator’s assessment of overall efficacy, “which was rated as excellent by the investigators for all subjects in the per-protocol population,” the company says. Coagadex was first approved 10/2015 for treating treatment hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency.