Dec. 09--Baxalta the biosciences spinoff of Baxter International, has received government approval for its newest drug, a genetically engineered treatment for a bleeding disorder that affects more than 3 million Americans.
The Food and Drug Administration on Tuesday approved Vonvendi for adults who suffer from von Willebrand disease, an inherited disease that can cause severe bleeding from the nose, gums and intestines, as well as into muscles and joints.
The disease is almost always passed down from a parent to a child, according to the Centers for Disease Control and Prevention. People suffering from the disorder often have trouble with blood clotting properly.
Baxalta called the treatment the first major therapeutic option for treating the disease in more than a decade, and the first treatment engineered by rearranging genetic material. The company said the drug would be available next year.
The approval follows two successful clinical trials of 69 adults with von Willebrand disease, with no safety concerns identified, the FDA said. The most common side effect was itching.
The FDA action marks the second major U.S. approval for a Baxalta drug in recent weeks. Last month, the FDA approved Adynovate, a treatment for patients with hemophilia A.
Baxalta, based in north suburban Bannockburn, makes products that treat rare bleeding disorders, immune deficiencies and cancer.
jrussell@tribpub.com
