May 9, 2008– 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.
(Source: www.pharmalive.com)
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