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Kedrion Biopharma receives FDA approval to package Koate DVI antihemophilic factor with Mix2Vial needle-free transfer device

MDBR Staff Writer Published 29 March 2016

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 Koate-DVI. Koate-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 Koate-DVI users. Its needle-free design lowers the risk of accidental needle sticks, which may ensure an additional measure of safety and control when Koate-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 Koate-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.

Mix2Vial will be available in the spring as a supplement to Koate-DVI packaging. For more information about Koate-DVI, please visit www.koate-dviusa.com/.

Koate®-DVI, Antihemophilic Factor (Human) is a plasma-derived product for the treatment of classic hemophilia (hemophilia A), in which there is a demonstrated deficiency of the plasma clotting factor, factor VIII. Koate-DVI has been used to treat hemophilia A for more than 10 years, and over 1.5 billion units have been infused into patients worldwide.

Koate-DVI contains naturally-occurring von Willebrand factor, which is co-purified as part of the manufacturing process. Koate-DVI has not been investigated for efficacy in the treatment of von Willebrand disease, and hence is not approved for such usage.



Source: Company Press Release