Micafungin Approved in Europe for Treatment and Prevention of Fungal Infections

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Micafungin Approved in Europe for Treatment and Prevention of Fungal

Infections

DG News*

Infections

http://www.docguide.com/news/content.nsf/news/852571020057CCF68525744

20069728E

TOKYO -- May 7, 2008 -- The antifungal micafungin sodium (Mycamine)

has been approved in Europe for the treatment of various Candida

infections.

The indications for adults, adolescents 16 years of age and older,

and the elderly are treatment of invasive candidiasis, treatment of

oesophageal candidiasis in patients for whom intravenous therapy is

appropriate, and prophylaxis of Candida infection in patients

undergoing allogeneic haematopoietic stem cell transplantation or

patients who are expected to have neutropenia (absolute neutrophil

count <500 cells/mcL) for 10 or more days.

For children (including neonates) and adolescents younger than 16

years of age, micafungin is indicated for treatment of invasive

candidiasis and prophylaxis of Candida infection in patients

undergoing allogeneic haematopoietic stem cell transplantation or

patients who are expected to have neutropenia (absolute neutrophil

count <500 cells/mcL) for 10 or more days

Micafungin is expected to launch first in the United Kingdom and

then across Europe shortly thereafter. The antifungal has been

available in Japan since December (Funguard for Infusion), where it

has established its therapeutic efficacy against fungal infections

caused by Aspergillus and Candida and safety through all therapeutic

results. Micafungin has been available in the United States since

May 2005 and is now indicated for treatment of patients with

candidaemia, acute disseminated candidiasis, Candida peritonitis,

and abscesses; treatment of patients with oesophageal candidiasis;

and prophylaxis of Candida infections in patients undergoing

haematopoietic stem cell transplantation.

SOURCE: Astellas Pharma Inc.