As a result of continuous enhancements made to the manufacturing process of hemostasis drug Thrombin-JMI, King Pharmaceuticals has received US Food and Drug Administration (FDA) approval for revised labelling for Thrombin-JMI.

The revised labelling recognises the capability of King's enhanced processes to reduce Factor V light chain content to undetectable levels using currently available methodologies.

"This new labelling for Thrombin-JMI reflects King's commitment to continually enhance the processes utilized in the manufacture of this product for the benefit of surgeons, healthcare professionals and patients," said Craig A. Paterson, MD, MBA, senior director, Medical Development, King Pharmaceuticals, Inc.

"Thrombin-JMI has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing process' capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown."

According to the company officials, some studies have proposed that if bovine Factor V is present in bovine thrombin, it may elicit the formation of antibodies that could cross-react with human Factor V and possibly lead to clinically significant bleeding (coagulopathy). Specific studies evaluating a causative relationship between bovine Factor V levels, human antibody formation to bovine proteins including thrombin and Factor V, and serious coagulopathies have never been performed. However, well-controlled clinical trials with Thrombin-JMI have not demonstrated an increase in coagulopathy. Therefore, the clinical significance of antibodies to bovine proteins remains unknown.

Thrombin-JMI is an active topical haemostat that achieves fast, active control of surgical bleeding (hemostasis). It is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small veins is accessible, or in conjunction with an absorbable gelatine sponge, USP. Since its approval more than 12 years ago, Thrombin-JMI has been used in an estimated 12 million patient procedures.