Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for Halaven (eribulin mesylate), in the monotherapy treatment of patients with locally advanced and metastatic breast carcinoma with progression after prior therapy with an anthracycline, a taxane and capecitabine.
The company submitted New Drug Application based on the results from a Phase II study (Study 211) of Halaven in order to deliver the medicine to patients as quickly as possible. Swissmedic has been reviewing the application based on Study 211 along with the global Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) vs Eribulin E7389). The application to Singapore has been approved in February 2011.
The Swismedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment. Breast cancer is the second most commonly diagnosed cancer worldwide and there are about 1.3 million new cases of the disease annually. More than 5,000 Swiss women have the disease and approximately 1,400 are likely to die annually.
Having already received approval in the United States in November 2010, in Singapore in February 2011, in March 17, 2011 in European Union and in April in Japan, the approval of Halaven by Swissmedic marks the fifth country or region for which the drug has been approved. Halaven is also currently under regulatory review in Canada.
True to its human health care (hhc) mission, Eisai remains committed to patients and their families and continue its stated goal of delivering Halaven to patients worldwide as quickly as possible.