Kedrion Announces Safer Manufacture Process for Koate Antihemophilic Factor

Note: This is an edited version of a Kedrion press release. To read the full release, click here. 
____________________
Kedrion Biopharma proudly announced that Koate® Double Viral Inactivation (DVI) Antihemophilic Factor (human) is now being manufactured using a process that further enhances the safety and purity of that product. 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. Koate-DVI belongs to the class of products known as “plasma-derived clotting factors,” all of which are manufactured using human plasma as starting material.
The enhanced manufacturing process now used with Koate-DVI involves applying a polyethylene glycol (PEG) depth filtration step during purification of the plasma used in the production of Koate-DVI. PEG depth filtration is one of several well-established techniques used in the purification of various types of liquid material, including biologics.
Koate-DVI manufactured using the new process is currently available in 500IU and 1000IU vials, and will be introduced with 250IU vials in mid-2015.
The new process shows an enhanced ability to remove or inactivate six (6) of seven (7) viruses tested. The degree of removal and/or inactivation of the seventh virus tested remains unchanged. Another aspect of the newly enhanced process is the ability to remove low levels of a transmissible agent similar to that which causes Creutzfeldt-Jakob disease (CJD).
All plasma-derived factors are associated with a risk of viral transmission. Although there have been no documented cases of viral transmission with a Kedrion Biopharma product, including Koate-DVI, the Company and its manufacturing partners routinely engage in ongoing process improvement in all areas of its operations, remaining alert to new and improved methods to reduce even theoretical risks to patients who use its products.
“This enhancement in the manufacture of Koate-DVI is another example of the ongoing commitment to ensuring the safety of all Kedrion products,” said Garrett E. Bergman, M.D., Senior Director, Kedrion Medical Affairs. “Patients and their physicians who prescribe Koate-DVI to treat hemophilia A can now experience an added level of comfort in knowing that steps have been taken to further reduce what was initially an extremely remote risk of viral transmission. We know the hemophilia community is keenly interested in these types of activities, and we are pleased to announce such positive steps today.”
Potency of Koate-DVI remain unchanged
Studies were undertaken to determine the effect of the manufacturing enhancements on the potency of Koate-DVI. Function can be determined by assays in clotting tests, which were performed. Results indicated that Factor VIII activity and antigen, von Willebrand factor potency and antigen, overall protein content, and content of albumin, fibrinogen and IgG remain unchanged.
There are no changes to reconstitution procedures, dosing or administration.
About Koate-DVI
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 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.
…
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.