Astellas’s European subsidiary has submitted a marketing authorization application under the centralized procedure to European Medicines Agency for Mycamine in April 2006. Following the review, the European Committee has granted the marketing authorization for Mycamine across the EU on April 25, 2008.
According to Astellas, this launch in Europe means that Mycamine/Funguard will be available in major overseas markets including North America, Asia and Europe, and Astellas is expecting that Mycamine will be a new option for the treatment of Candida infections throughout Europe. Funguard is the brand name for Mycamine in the Japanese market.
Astellas said that it is committed to developing a franchise in infectious diseases, and this launch in Europe will be a driving force to accelerate the expansion of this franchise.