Fort Lee, NJ – The FDA has granted approval to Kedrion Biopharma to package Koāte Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2Vial, a needle-free transfer device constructed of plastic with a built-in filter to enable fast, easy infusions.
The new packaging, expected to be available this spring, is designed to optimize safety when reconstituting Koāte-DVI in the treatment of hemophilia A, a rare genetic disorder caused by missing or defective factor VIII clotting protein.
Koāte-DVI, which contains naturally occurring von Willebrand factor co-purified as part of the manufacturing process, has been used to treat hemophilia A for more than 10 years.
Prior to the FDA approval to include Mix2Vial, the reconstitution of Koāte-DVI required the use of a double-ended transfer needle and three steps instead of two to prepare product for use.
“Safety and convenience are two of the most important considerations hemophilia patients and their healthcare providers have when reconstituting lyophilized factor therapy,” Neal Fitzpatrick, VP and North America commercial head at Kedrion, said. “(Mix2Vial’s) needle-free design lowers the risk of accidental needle sticks, which may ensure an additional measure of safety and control when Koāte-DVI is being reconstituted.”
Although hemophilia A is passed down from parents to children, about one-third of cases are caused by a spontaneous mutation, a change in a gene, according to the National Hemophilia Foundation.
The Centers for Disease Control and Prevention (CDC) reports that hemophilia occurs in approximately one in 5,000 live births and estimates that about 20,000 people of all races and ethnic groups are affected with hemophilia in the United States. More than 50 percent of patients with hemophilia A, which the CDC reports is four times as common as hemophilia B, have the severe form of hemophilia.
Kedrion states on its website that Koāte-DVI is not approved for the treatment of von Willebrand disease itself. That disease, which occurs with equal frequency among men and women, is an under-diagnosed blood disorder in which the blood does not clot properly. Although there is no cure for von Willebrand disease, treatment can control the symptoms, according to CDC.
(Sources: Kedrion Biopharma, National Hemophilia Foundation, The Centers for Disease Control and Prevention, Business Wire)