FDA approves IXINITY for treatment of hemophilia B in patients 12 years and under
IXINITY is now approved to treat all patients with the hemophilia B to help control bleeding episodes, as well as reduce the frequency of them.
FDA approves IXINITY sBLA for treatment of hemophilia B in patients 12 years and under © calin - stock.adobe.com
The FDA has approved a supplemental Biologics License Application (sBLA) for IXINITY (coagulation factor IX [recombinant]; Medexus Pharmaceuticals) for the on-demand, prophylactic, and perioperative treatment of pediatric patients 12 years and under with hemophilia B.
According to Medexus, IXINITY is an intravenous recombinant factor IX therapeutic which was previously approved for use in patients 12 years and up with hemophilia B.
However, following this approval, IXINITY is now approved to treat all patients with hemophilia B to help control bleeding episodes, as well as reduce the frequency of them.
Hemophilia B is a hereditary blood disorder that is a result of a deficiency of clotting factor IX in the blood, according to a company press release.
Symptoms may include trauma-induced or spontaneous bleeding into muscles, soft tissues, and joints, which can lead to joint damage, severe arthritis, and mobility reduction.
“IXINITY effectively prevented and controlled bleeding episodes in the phase 3/4 pediatric study,” said one of the study’s principal investigators, Johnny Mahlangu, BSc, MBBCh, MMed, FCPath.
He added, “The study supported the efficacy and safety of IXINITY in pediatric patients, and the pharmacokinetics and safety profile were consistent with those observed in adults, although dose adjustment may be needed in pediatric patients. The results thus provide further validation of the clinical utility of IXINITY as a treatment for all people living with hemophilia B.”
Reference:
FDA Approves Medexus's Supplemental Biologics License Application for IXINITY to Treat Hemophilia B in Pediatric Patients. Market Screener. March 27, 2024. Accessed March 28, 2024. https://www.marketscreener.com/quote/stock/MEDEXUS-PHARMACEUTICALS-I-49601873/news/FDA-Approves-Medexus-s-Supplemental-Biologics-License-Application-for-IXINITY-to-Treat-Hemophilia-B-46299205
