Astellas' Mycamine(R) (micafungin) Licensed For Use In Europe To Treat Serious Fungal Infections

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 May 2008 - 1:00 PDT

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The European Medicines Agency (EMEA) has announced the marketing authorisation of Mycamine®, 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 U.K and across the European market 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. The Company 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.

"We are delighted that Mycamine® is now licensed for use in Europe." said Alan Houston, MBBS, MRCP, FFPM, Senior Vice President, Research and Development, Astellas Pharma Europe. "It means that doctors will now have a new option to treat both their adult and paediatric - including neonatal - patients with."

Recognising the increasing need for new products to fight the growing epidemic caused by healthcare associated infections, Astellas is committed to building a strong anti-infectives franchise. This is reflected by its extensive clinical trial programme which has been very positively received by key opinion leaders in the area.

Mycamine

The indications for adults, adolescents ≥ 16 years of age and elderly are: Treatment of invasive candidiasis; Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; 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 / μl) for 10 or more days. For children (including neonates) and adolescents <16 years of age, Mycamine is indicated for: Treatment of invasive candidiasis; 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 / μl) for 10 or more days.

Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organisation is committed to becoming a global category leader by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. In Europe, Astellas markets products in the areas of Immunology, Urology, Dermatology and Cancer. Astellas Pharma Europe has 20 affiliate offices located across Europe, the Middle East and Africa, one R&D site and three manufacturing plants with nearly 3000 staff.

Astellas Pharma Europe Ltd., Lovett House, Lovett Road, Staines, Middlesex TW18 3AZ

Astellas Pharma Europe Ltd.

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