Kedrion Biopharma announced that the Food and Drug Administration (FDA) has approved the packaging of Koate Double Viral Inactivation (DVI) Antihemophilic Factor VIII (human) with Mix2Vial, a needle-free transfer device. 

Koate-DVI is a plasma-derived product indicated for use in the treatment of hemophilia A. The administration of Koate-DVI provides an increase in plasma levels of Factor VIII and can temporarily correct the coagulation defect in these patients.

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The new approved packaging allows patients enhanced safety and convenience when reconstituting Koate-DVI, and the needle-free design reduces the risk of accidental needle sticks. The Mix2Vial device is made of plastic with a built-in filter that allows for faster and easier infusions. Moreover, the new device requires fewer steps for product preparation with a fast vial-to-vial transfer. 

Prior to the Mix2Vial packaging, Koate-DVI reconstitution required the use of a double-ended transfer needle and three steps to prepare the product prior to administration. 

The Mix2Vial vials will launch in the spring as a supplement to the Koate-DVI packaging. Koate-DVI is currently available as 250 IU, 500 IU, and 1000 IU strengths in single-use vials.

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