Astellas Presents Data on Hospital-Acquired Infection Treatments

Study results presented at the 17th European Congress of Clinical Microbiology and Infectious Diseases 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, according to Astellas Pharma.

Hospital-acquired, or nosocomial, infections are one of the leading causes of death and increased morbidity among patients in a hospital setting. Data presented from ATLAS 1 and ATLAS 2, two multinational Phase III studies, show that telavancin was found to be effective for the treatment of patients with complicated skin and skin-structure infections, including those caused by Gram-positive organisms such as methicillin-resistant Staphylococcus aureus.

The results of the two double-blind, parallel studies, in which 1,867 patients were treated, showed that telavancin compared favorably with standard therapy in clinical cure, microbiological eradication and overall therapeutic response rates.

Telavancin is currently undergoing regulatory review by the FDA. The company submitted a new drug application in Februrary. 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, according to Astellas.

Data presented on micafungin demonstrate broad-spectrum efficacy against Candida infections. More specifically, findings show 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. Studies also show that in pediatric patients with invasive candidiasis or candidaemia, micafungin was as effective as standard therapy with L-AmB, with fewer patients experiencing treatment-related adverse events and fewer discontinuations.

Micafungin is currently under review by the European Medicines Agency. It is approved in the U.S. for the treatment of esophageal candidiasis and for the prophylaxis of fungal infections caused by Candida in patients who are undergoing a haematopoietic stem cell transplant.