Economía

COMUNICADO: La Comisión Europea concede la autorización de marketing a DIFICLIR(TM), de Astellas Pharma Europe Ltd., para su uso en

1. European Commission. Community register of medicinal products for human use. http://ec.europa.eu/health/documents/community-register/html/h733.htm. último acceso el 12 de diciembre de 2011. 2. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol 2011;8:17-26. 3. Simor AE, et al. Clostridium difficile in Long-term-care facilities for the elderly. Infect Control Hosp Epidemiol. 2002;23:696-703. 4. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4. 5. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. NEJM. 2010;362;3:197-205. 6. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011;364:422-31. 7. Crook D, et al. Randomized clinical trial (RCT) in Clostridium difficile infection (CDI) confirms equivalent cure rate and lower recurrence rate of fidaxomicin (FDX) versus vancomycin (VCN). 20th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); Viena, Austria, del 10 al 13 de abril de 2010; Abstracto LB2401. 8. Tannock GW, et al. A new macrocyclic antibiotic, fidaxomicin (OPT-80), causes less alteration to the bowel microbiota of Clostridium difficile-infected patients than does vancomycin. Microbiology 2010;156:3354-9. 9. Food and Drug Administration. FDA approves treatment for Clostridium difficile infection [Internet]. [actualizado el 27 de mayo de 2011; citado el 16 de septiembre de 2011]. Disponible desde http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htm. 10. DIFICID US Prescribing Information. Optimer Pharmaceuticals, Inc. 2011. 11. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis 2005;40:1591-7.12. Ghantoji SS, et al. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect 2010;74:309-18.

12. Ghantoji SS, et al. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect 2010;74:309-18.

CONTACTO: Katy Compton Bishop, Ruder Finn, Tel: +44(0)20-7462-8922E-mail : kcompton-bishop@ruderfinn.co.uk; Mindy Dooa, Astellas PharmaEurope Ltd., Tel : +44(0)1784-419-444, E-mail : mindy.dooa@eu.astellas.com

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