Astellas' Mycamine gets CHMP OK

Astellas' Mycamine (micafungin sodium), a treatment for systemic fungal infections, which are serious, life-threatening conditions, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The Japanese drug major expects to obtain a European Commission decision in May.

Alan Houston, senior vice president of R&D at Astellas Pharma Europe, noted that approval would provide access to "a new, highly effective treatment for systemic fungal infections in adult and pediatric patients including neonates. This is particularly important as systemic fungal infections have a mortality rate of up to 60%." Mycamine is a novel treatment for a serious fungal infection known as invasive candidiasis, and its efficacy and safety have been demonstrated in an extensive and robust clinical development program including more than 3,500 patients in 16 clinical trials, Astellas noted.