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Home Industry News Astellas receives positive CHMP opinion for Mycamine

Astellas receives positive CHMP opinion for Mycamine

25th February 2008

Astellas Pharma has announced that it has received a positive opinion from the committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) regarding the marketing authorisation of Mycamine (micafungin sodium).

The company’s subsidiary in the EU had submitted an application for marketing authorisation for the drug in April 2006 and the compound has since been reviewed under the centralised procedure, with the CHMP issuing its positive opinion as a result of a comprehensive package of data.

Mycamine has been given a positive opinion for approval as a treatment for invasive candidiasis and the prevention of candida infectionin patients expected to have neutropenia and those undergoing allogeneic haemotopoietic stem cell transplantation.

The positive opinion also extends to the use of the drug in adults as a treatment of oesophageal candidiasis where intravenous therapy is appropriate.

“Astellas is expecting that Mycamine will contribute to the treatment of fungal infections throughout Europe,” the company reports.

It adds that its expects marketing authorisation to be granted for the drug in this indication by the EMEA in May 2008.

In January 2007, Astellas announced the availability of micafungin sodium in 100mg vials for injection.

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