Data on telavancin and micafungin hold promise of new therapeutic options in fight against serious infectious disease

Studies reinforce Astellas commitment to overcoming critical shortage of new antimicrobial agents

– Studies reinforce Astellas commitment to overcoming critical shortage of new antimicrobial agents –

Munich, 1 April 2007 – Study results presented at the 17th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) show that the antibiotic telavancin, and the antifungal micafungin, both have the potential to meet a significant unmet need in the fight against serious hospital-acquired infections (HAIs).
Hospital-acquired, or nosocomial infections, are one of the leading causes of death and increased morbidity amongst patients in a hospital setting.  Estimates suggest that HAIs cost the UK economy £1 billion a year.  The greatest contributor to this cost is the increased length of hospital stay for patients with infection. , ,    

Telavancin data
Data presented from ATLAS 1 and ATLAS 2, two multinational phase 3 studies, show that telavancin was found to be effective for the treatment of patients with complicated skin and skin structure infections (cSSSIs), including those caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). ,    

The results of the two double blind parallel studies, in which 1,867 patients were treated, showed that telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates.  The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections due to resistant bacteria.

Commenting on the study results, investigator Professor M Stryjewski, Duke Clinical Research Institute, Durham, North Carolina, USA said, “Antibiotic resistant bacterial infections are an emerging issue in hospitals and there is a real risk that we are fast running out of effective treatment options. The results of ATLAS 1 and ATLAS 2 demonstrate that telavancin may offer a new option in our fight against serious bacterial infections”.

Telavancin is currently undergoing regulatory review at the U.S. Food and Drug Administration (FDA). Telavancin is a novel, rapidly bactericidal lipoglycopeptide with activity against important Gram-positive bacteria. Telavancin possesses a unique, multivalent, multifunctional mode of action that inhibits bacterial cell wall synthesis and disrupts the functional integrity of the bacterial cell membrane.

Micafungin data
Micafungin data presented show that micafungin demonstrates broad-spectrum efficacy against Candida infections.  More specifically data showed that in adult patients with deep, invasive Candida, micafungin was associated with efficacy comparable to established treatments, liposomal amphotericin B (L-AmB) and intravenous caspofungin,  and that there were significant safety advantages of micafungin over L-AmB in terms of a difference in acute infusion related reactions and Estimated Glomerular Filtration Rate (eGFR).   Data presented also showed that in paediatric patients with invasive candidiasis or candidaemia, micafungin was as effective as standard therapy with AmBisome® (L-AmB), with fewer patients experiencing treatment-related adverse events and fewer discontinuations.

Micafungin is currently undergoing clinical evaluation at the EMEA. Micafungin is licensed in the US for the treatment of oesophageal candidiasis and for the prophylaxis of fungal infections caused by Candida in patients who are undergoing a haematopoietic stem cell transplant.

Commenting on the data presented at ECCMID, Dr John Bolodeoku, European Senior Medical Director, Astellas Pharma Inc. said, “Effective prevention and treatment strategies for serious hospital acquired infections represent a significant challenge in healthcare. Astellas look forward to supporting healthcare professionals in their fight against these often fatal infections”.

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