Taxus in Japan
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific launches Taxus Liberté paclitaxel-eluting stent after gaining reimbursement from Japan's National Health Insurance System March 2. Taxus Liberté was approved by the Ministry of Health, Labor and Welfare Jan. 28, and is the "only second-generation drug-eluting stent in Japan," according to Boston Scientific (1"The Gray Sheet" Feb. 2, 2009, p. 15). The firm has pointed to Liberté as an example of accelerating approval times in Japan, where the regulatory pathway has historically been difficult to navigate for device makers. Abbott filed for Japanese approval of the Xience V everolimus-eluting stent in June. Boston Sci also markets its first-generation Taxus Express2 stent in Japan. Liberté was introduced in the U.S. last fall (2"The Gray Sheet" July 28, 2008, p. 10)