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Mycamine approved in EU

Astellas Pharma has announced that the European Medicines Agency has granted marketing authorisation for its drug, Mycamine (micafungin)
Astellas Pharma has announced that the European Medicines Agency (EMEA) has granted marketing authorisation for its drug, Mycamine (micafungin).

The drug has been developed for the treatment of invasive candidiasis, oesophageal candidiasis and prophylaxis in patients undergoing allogeneic haematopoietic stem cell transplantation. The company has said that the drug will be released in the UK and across European markets immediately.

Professor David Denning of the University of Manchester said: "The approval of micafungin is very good news for patients with life-threatening fungal infections in Europe."

"Particularly welcome are the indications for fungal infections in children and babies, often a neglected group in the early drug approval process," he concluded.

Mycamine has the potential to help curb the spread of the epidemic of healthcare-associated infections and represents part of Astellas' drive to shore up its anti-infectives business. The medicine was launched in the US three years ago and in Japan in 2002. Since being made available in these markets it has been used to treat 350,000 patients.

Senior vice-president of R&D at Astellas, Alan Houston, said that the marketing authorisation means "doctors will now have a new option to treat both their adult and paediatric - including neonatal - patients with".

7th May 2008


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