September 19, 2011 — The European Commission (EC) has approved telavancin HCl once-daily injection (Vibativ, Astellas Pharma Europe, Ltd, and Theravance, Inc) for the treatment of adults with hospital-acquired pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant strains of Staphylococcus aureus (MRSA).
"The approval of [telavancin] can provide European healthcare professionals with a new, effective hospital antibiotic option for patients with hospital-acquired pneumonia caused by MRSA," said Ken Jones, president and chief executive officer of Astellas Pharma Europe, in a company news release.
The injectable lipoglycopeptide antibiotic is a synthetic derivative of vancomycin; both agents inhibit bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan. Telavancin also binds to the bacterial membrane, disrupting its barrier function.
The drug's approval for the treatment of nosocomial pneumonia was based on data from 2 large multicenter, multinational, double-blind phase 3 clinical studies (ATTAIN I and II; n = 1503) that compared telavancin (10 mg/kg every 24 hours) with vancomycin (1 g every 12 hours) in the treatment of hospital-acquired pneumonia or ventilator-associated pneumonia resulting from gram-positive pathogens. Concomitant treatment with gram-negative antibiotics was allowed for polymicrobial infections.
Results showed that telavancin was noninferior to vancomycin for achieving clinical cure of infections (82.7% vs 80.7%; 95% confidence interval [CI] for the difference, −4.3% to 7.7%), including those caused by MRSA (81.8% vs 74.1%; 95% CI for difference, −3.5% to 19.3%).
"We are in the midst of a worrisome increase in the occurrence of MRSA pneumonia," said Ethan Rubinstein, MD, the co–principal investigator in the ATTAIN studies and head of infectious diseases and professor of medicine at the University of Manitoba, Winnipeg, Canada, in a Theravance news release. "In addition, there is a growing incidence of MRSA with reduced susceptibility to vancomycin, leaving too few treatment options."
A subgroup analysis revealed that patients with ventilator-associated pneumonia exhibited a trend toward higher clinical cure rates with telavancin relative to vancomycin (80.3% vs 67.8%).
Treatment-emergent adverse events were reported at similar rates among patients receiving either telavancin or vancomycin (82% vs 81%), most commonly including diarrhea (11% vs 12%), constipation (9% for both), and anemia (9% vs 11%). Similar proportions of patients experienced renal impairment (10% vs 8%) and QTc interval prolongation (8% vs 7%).
EC approval allows telavancin to be marketed for the treatment of nosocomial pneumonia in all member states of the European Union, including Norway and Iceland.
Telavancin is approved by the US Food and Drug Administration and Health Canada for the once-daily treatment of adults with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin-resistant and methicillin-susceptible strains of S aureus.
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Cite this: Europe Approves Telavancin for Hospital-Acquired Pneumonia - Medscape - Sep 19, 2011.