Kyowa Hakko Kirin Moves Forward With KW-3357

After successful phase 3 clinical trials, Japanese company Kyowa Hakko Kirin has filed a marketing approval application for KW-3357, a recombinant human antithrombin used to treat patients with congenital anti-thrombin deficiency (CAD) and Disseminated Intravascular Coagulation (DIC) accompanied by a decrease in anti-thrombin.

KW-3357 is a recombinant preparation developed to possess the exact same amino acid sequence of human plasma derived AT. Because KW-3357 is recombinant, researchers expect that the drug will decrease the risk of infection common when using preparations derived from humans.

The phase 3 clinical trial, which began in 2011, included two open-label studies. These studies tested KW-3357 versus both plasma-derived AT and heparins/heparinoids in patients with DIC. In both studies, the treatment performed well and met all safety guidelines of the Japanese Ministry of Health.   

Anti-thrombin (AT) is a glyco-protein produced by the liver and is important for controlling blood clots. AT deficiencies are either hereditary (CAD) or develop as a result of cancer or other serious infections (DIC). AT decreases or deficiencies can elevate the risk of abnormal blood clots or internal bleeding. This can cause complications during surgery and can increase the risk of developing pulmonary embolism.

Between 7-10 percent of cancer patients develop DIC, and, according to the Genetics Home Reference website, CAD affects one in every 2,000-3,000 people. Women with either condition are at increased risk during pregnancy.