Staines, England (ots/PRNewswire) -
- New Treatment Option Contributes to Fight Against Healthcare
Astellas Pharma Europe Ltd(i) announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) issued a positive opinion by consensus, recommending a
marketing authorisation for Mycamine(R), a treatment for systemic
fungal infections, which are very serious, life-threatening
The CHMP's positive recommendation is a critical step in the
approval process, and Astellas expects to obtain the European
Commission decision in May.
"This positive opinion from the CHMP for Mycamine(R) is great
news for both doctors and adult and paediatric patients including
neonates in Europe," said, Alan Houston MBBS, MRCP, FFPM, Senior Vice
President, Research & Development, Astellas Pharma Europe. "It means
that they will have access to a new, highly effective treatment for
systemic fungal infections in adult and paediatric patients including
neonates. This is particularly important as systemic fungal
infections have a mortality rate of up to 60%(1)," he added.
Mycamine(R) is a novel treatment for a serious fungal infection
known as invasive candidiasis, and its efficacy and safety have been
demonstrated in an extensive and robust clinical development
programme including more than 3,500 patients in 16 clinical trials.
These trials not only cover large Mycamine(R) patient numbers but a
broad range of patients including nearly 300 children. Mycamine(R) is
the market leader in Japan where it was launched in 2002 (Brand Name
in Japan: Funguard(R)), and in the US, where Mycamine(R) was launched
in 2005, the product has already achieved a 20% market share. In
these two major markets more than 350,000 patients have been treated
with the product.
Invasive candidiasis, with reported mortality rates ranging from
40% to 75% of patients, is a frequent cause of morbidity and
mortality in high risk patients.(1) Medical advances in the
management of a wide range of conditions have been accompanied by an
increase in the number of patients at risk of invasive candidiasis.
These include solid organ or haematopoietic stem cell
transplantation, improved management of patients with burns, cancers
and of low weight infants, and increased numbers of patients with HIV
infection or AIDS. Astellas seeks to satisfy unmet treatment needs
beyond those afforded by existing therapies by providing treatment
alternatives for invasive candidiasis.
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.
Telavancin, another Astellas product currently under review in the EU
regulatory process, is a novel, bactericidal, once-daily injectable
antibiotic for the treatment of complicated skin and skin structure
infections caused by Gram-positive bacteria, including resistant
pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
The product review for telavancin continues under the EMEA's
Centralised Procedure following its initial submission in April 2007.
(i)Astellas Pharma Europe Limited, 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 company by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe is responsible for 20 affiliate
offices located across Europe, the Middle East and Africa, two R&D
sites and three manufacturing plants with approximately 3,300 staff.
Astellas Pharma Europe Limited, Lovett House, Lovett Road,
Staines, Middlesex TW18 3AZ
(1) Gudlaugsson O, et al. Attributable Mortality of Nosocomial
Candidemia, Revisited. Clin Infect Dis 2003; 37: 1172-7
Contacts for enquiry or additional information:
Astellas Pharma Europe
Red Door Communications
Philip R. Sheldon, Director
Direct line: +44(0)20-8392-8093
Jas Kaur, Account Executive
Mobile : +44(0)7904-292-908
ots Originaltext: Astellas Pharma Europe Limited
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