The European Medicines Agency (EMEA) has granted marketing authorisation for Mycamine.
Mycamine (micafungin) is Astellas Pharma Europe’s treatment for invasive candidiasis, oesophageal candidiasis and prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.
Mycamine will initially be available in the UK, with the rest of the European market following shortly after this.
Professor David Denning of The University of Manchester said of the announcement: “The approval of micafungin is very good news for patients with life-threatening fungal infections in Europe.
“Astellas has conducted a number of large, high quality clinical studies in Candida infections with impressive results.
“Particularly welcome are the indications for fungal infections in children and babies, often a neglected group in the early drug approval process.”
The efficacy and safety of Mycamine have been demonstrated in a clinical development programme including more than 3,500 patients in 16 clinical trials.
The trials included nearly 300 children.
Mycamine was launched in Japan in 2002 and in the US three years ago. In these two major markets more than 350,000 patients have been treated with the product.