FDA Approves Needle-Free Transfer Device for Hemophilia A Product

Note: The following in an edited press release from Kedrion Biopharma. The original release can be read in its entirety here.

Kedrion Biopharma has gained approval from the U.S. Food and Drug Administration to package Koāte® Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2Vial™, a needle-free transfer device. The new packaging is designed to offer hemophilia patients optimized safety and convenience when reconstituting Koāte-DVI. Koāte-DVI is used in the treatment of hemophilia A, a rare, inherited condition characterized by a person’s inability to form effective blood clots following an injury, and by spontaneous bleeding into one’s joints. “Safety and convenience are two of the most important considerations hemophilia patients and their healthcare providers have when reconstituting lyophilized factor therapy,” said Neal Fitzpatrick, Vice President, Commercial Head, North America at Kedrion Biopharma. “Knowing this, we are extremely pleased to be introducing Mix2Vial to Koāte-DVI users. Its 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.
In addition, the Mix2Vial reduces the number of steps involved in preparing product for use. We anticipate that patients, their parents, and healthcare treaters will welcome these advances.” Before the availability of 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. The Mix2Vial is constructed of plastic with a built-in filter that works to enable fast, easy infusions.