Ixinity is a replacement therapy that Aptevo Therapeutics developed. The U.S. Food and Drug Administration (FDA) approved the treatment in 2015 for adults and children 12 or older who have hemophilia B. Medexus Pharmaceuticals acquired Ixinity from Aptevo in March 2020.
How does Ixinity work?
Hemophilia B is a bleeding disorder caused by the deficiency of one of the factors required for blood clotting called factor IX (FIX). This results in delayed blood clotting.
Ixinity is a recombinant human factor IX produced in Chinese hamster ovary (CHO) cells. When injected into hemophilia B patients, Ixinity replenishes FIX levels and restores the normal blood clotting process. Doctors recommend it for the control and prevention of bleeding episodes. They also recommend it to manage blood loss during surgery.
Ixinity in clinical trials
A multi-center Phase 2/3 clinical trial (NCT00768287) assessed the pharmacokinetics (movement in the body), safety, and efficacy of Ixinity in 77 hemophilia B patients. Results showed that patients tolerated Ixinity well. The most common adverse side effect was headaches, which only 2.6% of participants experienced. There were no reports of FIX inhibitors during the treatment, and Ixinity was effective as a prophylactic (preventive) treatment. Moreover, one or two infusions of Ixinity resolved 84% of bleeds. Researchers rated its ability to control these bleeds as excellent or good.
A multicenter, non-randomized, open-label Phase 3 study (NCT01271868) evaluated the pharmacokinetics, safety, and efficacy of Ixinity in hemophilia B patients younger than age 12. Results showed that Ixinity was safe and children tolerated it well. During the trial, there were 61 bleeding episodes among the 11 patients receiving Ixinity as a prophylactic treatment. Of these, six (10%) resolved with no infusions of Ixinity and 44 (72%) resolved after one infusion of Ixinity. Five (8%) bleeding episodes required two infusions, and six (10%) required three to five infusions of Ixinity. Researchers rated bleed control as excellent in 65% of bleeding episodes, good in 32%, and fair in 3%. The most common adverse side effect was hyperhidrosis (excessive sweating), while one patient experienced fever. Pharmacokinetic analyses showed that the body metabolized Ixinity faster and patients younger than 12 showed lower recovery compared to patients older than 12.
Ongoing clinical trials
A single-arm, open-label Phase 3/4 clinical trial (NCT03855280) is recruiting participants in Moldova, South Africa, and Ukraine to evaluate the pharmacokinetics, safety, and efficacy of Ixinity prophylaxis in children younger than 12 with severe or moderately severe hemophilia B. For the study, researchers will divide patients into two groups: those younger than 6 and those 6 to 12. The estimated completion date is September 2021.
Last updated: March 30, 2020
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