Pharma/Biotech Update: Pediatric Indication for RIXUBIS
December 9, 2013; Posted by: webleed staff
Baxter International Inc. announces submission of application to the United States Food and Drug Administration (FDA) for a pediatric indication for RIXUBIS [Coagulation Factor IX (Recombinant)] to treat hemophilia B.
According to BusinessWire, Baxter Pharmaceuticals sent out a press release today stating they have applied to have their hemophilia B (factor IX deficiency) coagulation factor medication, RIXUBIS, submitted f0r pediatric indication.
”Routine prophylactic infusions can be particularly beneficial for children with hemophilia, particularly if they are started early to help prevent joint bleeding,” explained lead investigator Tomasz Urasinski, Pomeranian Medical University, Department of Paediatrics, Haematology and Oncology, Szczecin, Poland. ”The clinical evidence suggests that RIXUBIS prophylaxis can offer hemophilia B patients a reduction in bleeding episodes while also being tolerable, an important factor for this young population.”
Anders Ullman, M.D., Ph.D., vice president of global research and development in Baxter BioScience noted, ”These positive results among a pediatric patient population are consistent with those observed in the RIXUBIS pivotal study among adult patients with hemophilia B. We submitted these data as part of our application for a pediatric indication for RIXUBIS to advance effective therapeutic solutions for children with hemophilia B.’
Always an exciting time in the bleeding disorders community when new drug and therapy advancements come to the surface. Stay tuned to read more about the development of Baxter’s application. Click the link to read more about Baxter International, Inc.
Photo Credit – Baxter International, Inc.
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