April 20, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Illinois-based Baxter International, Inc. released data from its Phase III clinical trial of BAX 111 on April 17, a stand-alone recombinant treatment for von Willebrand Factor. The data showed that the drug achieved high safety ratings and it met its primary endpoint. At the time of this report, Baxter could not be reached for comment.
The primary efficacy endpoint for the drug was defined as the number of patients who were able to control bleeding episodes. The efficacy rate for all bleeding instances (192) was 96.9 percent, considered to be “excellent” by researchers. There were no reports of thrombotic events or severe allergic reactions during the trial.
“Today, people with von Willebrand disease have limited treatment options if they require replacement therapy with von Willebrand factor containing concentrate,” said Joan Gill, lead author of the trial. “This study has provided valuable evidence of the potential benefit of BAX 111 as a recombinant therapeutic option to resolve bleeding events.”
Baxter recently made news on April 16 when it decided to submit a New Drug Application to Japan’s Ministry of Health Labor and Welfare for the approval of BAX 855. This product is an investigational recombinant factor VIII for the treatment of hemophilia A.
Addressing Bleeding Disorders
Von Willebrand Disease is known as an inherited bleeding disorder that can occur starting at birth. However, it is not the only blood condition known to impact humans. That being said, research is continuously being conducted to uncover new treatments.
Ethicon announced on April 6 that the U.S. Food and Drug Administration had approved of its Evarrest Fibrin Sealant Patch to control bleeding during surgery. This common problem during surgery is typically one of the most threatening complications that can arise for surgeons.
“The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve,” said Krishna Athota, trauma and critical care surgeon at the University of Cincinnati College of Medicine. “This expanded indication for Evarrest reinforces this innovation’s potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery.”
Hemophilia is a genetic disorder that prevents the blood from clotting normally. There are various forms of hemophilia, and it is thought that more than 400,000 people around the world have the condition. Currently, there is no defined cure for this condition.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
