tag:blogger.com,1999:blog-5538539029544017314.post-81697749362339345982008-05-12T03:39:00.000-07:002008-05-12T03:41:03.531-07:00<span class="zemanta-img" style="margin: 1em; display: block; float: right;"><a href="http://en.wikipedia.org/wiki/Image:Glabrata.jpg" target="_blank"><img src="http://upload.wikimedia.org/wikipedia/en/thumb/7/7b/Glabrata.jpg/202px-Glabrata.jpg" alt="Glabrata." style="border: medium none ; display: block;"></a><span style="margin: 1em 0pt 0pt; display: block;">Image via <a href="http://en.wikipedia.org/wiki/Image:Glabrata.jpg" target="_blank">Wikipedia</a></span></span>The European Medicines Agency (EMEA) has announced the marketing authorisation of Mycamine®, <a href="http://en.wikipedia.org/wiki/Astellas_Pharma" title="Astellas Pharma" rel="wikipedia" target="_blank" class="zem_slink">Astellas Pharma</a> Europe's treatment for invasive candidiasis, oesophageal candidiasis and prophylaxis of <a href="http://en.wikipedia.org/wiki/Candida_%28genus%29" title="Candida (genus)" rel="wikipedia" target="_blank" class="zem_slink">Candida</a> 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.<br /><span id="fullpost"><br /><div id="lw_context_ads"><br />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."<br /><br />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.<br /><br />"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."<br /><br />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.<br /><br />Mycamine<br /><br />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 &lt; 500 cells / μl) for 10 or more days. For children (including neonates) and adolescents &lt;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 &lt; 500 cells / μl) for 10 or more days.<br /></div><br /></span><div id="zemanta-pixie" style="margin: 5px 0pt; width: 100%;"><a id="zemanta-pixie-a" href="http://www.zemanta.com/" title="Zemified by Zemanta"><img id="zemanta-pixie-img" src="http://img.zemanta.com/pixie.png?x-id=37686deb-be26-4465-a7eb-3db813750a07" style="border: medium none ; float: right;"></a></div><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/5538539029544017314-8169774936233934598?l=clinicaltrialsweb.blogspot.com' alt='' /></div>RickyFannoreply@blogger.com0