Astellas' Mycamine(R) (micafungin) Licensed for Use in Europe to Treat Serious Fungal Infections
STAINES, England, May 7/PRNewswire/ -- The European Medicines Agency (EMEA) has announced the marketing
authorisation of Mycamine(R), Astellas Pharma Europe's treatment for invasive
candidiasis, oesophageal candidiasis and prophylaxis of Candida infection in
patients undergoing allogeneic haematopoietic stem cell transplantation.
Mycamine(R) 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(R) 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(R) 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(R) 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.
Notes to Editors
Mycamine
The indications for adults, adolescents 16 years of age or older 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 / microlitre)
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
/ microlitre) 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
For more information please contact:
Mindy Dooa
Astellas Pharma Europe
Tel: +44(0)1784-419-408
Email: mindy.dooa@eu.astellas.com
Rosie Allan
Red Door Communications
Tel: +44(0)20-8392-6931
Email: rallan@rdcomms.com
Jas Kaur
Red Door Communications
Email: jkaur@rdcomms.com
Source: Astellas Pharma Europe Limited
For more information please contact: Mindy Dooa, Astellas Pharma Europe, Tel: +44(0)1784-419-408, Email: mindy.dooa@eu.astellas.com; Rosie Allan, Red Door Communications, Tel: +44(0)20-8392-6931, Email: rallan@rdcomms.com; Jas Kaur, Red Door Communications, Email: jkaur@rdcomms.com
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