Kedrion Biopharma Receives FDA Approval to Package Koate® Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2VialTM Needle-Free Transfer Device
- Kedrion Biopharma extends its focus on patients by offering Mix2Vial, a needle-free, double-ended, all plastic filter transfer set for use in reconstituting Koate® Double Viral Inactivation (DVI) Antihemophilic Factor (human), a lyophilized (i.e., powdered) human factor-derived clotting factor
- Mix2 Vial reduces exposure to accidental needle sticks, ensures consistent volume withdrawal, and is presented in touch-free packaging
- Mix2Vial, designed for minimal residual volume and overfill, can be used with all assays of Koate-DVI
- Mix2 Vial offers convenience to patients: Two steps—instead of three—are required to prepare product for infusion
Fort Lee, NJ— March 28, 2016
Kedrion Biopharma has gained approval from the U.S. Food and Drug Administration to package Koate® 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 Mix2 Vial 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.
Mix2 Vial 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/.
Koāte®-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. Koāte-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. Koāte-DVI contains naturally-occurring Von Willebrand factor, which is co-purified as part of the manufacturing process. Koāte-DVI has not been investigated for efficacy in the treatment of von Willebrand's disease, and hence is not approved for such usage. Please refer to the Koate-DVI prescribing information for details.
About Mix2Vial™ The Mix2Vial® needle-free system enables simple, fast vial-to-vial transfer and mixing for the reconstitution of lyophilized drug products. The reconstituted drug is available for immediate aspiration into the syringe used for injection.
About Hemophilia A
Hemophilia A is an inherited bleeding disorder in which a person’s blood does not clot properly. People with hemophilia A are missing or have low levels of certain clotting factors. Clotting factors are proteins that help blood clot. An effective clot is needed to seal wounds and stop bleeding. Lack of clotting factors puts a person at risk for longer bleeding episodes and other complications.
Important Safety Information for Koate-DVI
Koāte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma-clotting factor, factor VIII.
Koāte-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products. Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.
When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored for signs of progressive anemia. Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. In clinical studies, adverse reactions included tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling. Please refer to the Koate-DVI prescribing information for details. Individuals are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, immune system deficiencies
and Rh sensitization. Kedrion Biopharma Inc, the US subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched US operations in 2011, but the company’s international roots stretch back several decades in the production of blood and plasma-derived products. Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves.
Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.