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# Medexus’ Hemophilia B Factor Gets Expanded Use
- URL: https://www.fdaweb.com/medexus-hemophilia-b-factor-gets-expanded-use/
- Published: 2024-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:26:43.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156660

FDA has approved a Medexus Pharmaceuticals supplemental BLA for Ixinity \[coagulation factor IX (recombinant)\] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. With this approval, the intravenous recombinant factor IX therapeutic is now approved for use in all patients with hemophilia B, the company says.

The expanded indication’s approval is based on data from a Phase 3/4 study that evaluated the pharmacokinetics (PK), safety, and efficacy of Ixinity as a prophylactic treatment in previously treated pediatric patients under 12 years of age with severe or moderately severe hemophilia B, according to the company. “The study demonstrated that prophylaxis with Ixinity was associated with low annualized bleeding rates, effective control of bleeding episodes, consistent PK, and a consistent safety profile,” it says.

Regarding safety, the most common adverse reaction observed in more than 2% of patients in clinical trials was headache, Medexus adds.