Eisai gets Swiss approval for Halaven

Japanese drug major Eisai (TYO: 4532), says that its Halaven(eribulin) has been  approved for use in Switzerland by Swissmedic, the Swiss Agency for Therapeutic Products, as a monotherapy treatment of patients with locally advanced and metastatic breast carcinoma with progression after prior therapy with an anthracycline, a taxane and capecitabine.

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, the company noted.

Eisai submitted a New Drug Application based on the results from a Phase II study (Study 211) of eribulin in order to deliver the medicine to patients as quickly as possible. The approval was based upon the Phase II and Phase III data. The drug was cleared by the European Commission in March and last month debuted in the UK (The Pharma Letter April 20). Eribulin was approved in the USA in November 2010, in Singapore in February 2011 and Japan in April 2011.