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FDA Panel Has Mixed Opinion of Vibativ (Telavancin) for Nosocomial Pneumonia

Committee thinks drug should be used only if other alternatives are unsuitable (Nov. 29)
The committee voted 6 (yes) to 9 (no) with regard to whether the results provided substantial evidence of the safety and effectiveness of Vibativ for the requested indication of the treatment of NP, including ventilator-associated pneumonia, caused by susceptible isolates of the certain Gram-positive microorganisms –– i.e., both methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus (MRSA and MSSS, respectively) and Streptococcus pneumoniae.

However, the committee also voted 13 (yes) to 2 (no) that the results provided substantial evidence of the safety and effectiveness of Vibativ for the treatment of NP when other alternatives are not suitable.

Advisory committees provide the FDA with independent opinions and recommendations from outside experts on applications to market new drugs. The outside experts receive summary information about the applications and copies of the FDA's review of the application documents. Based on this information, the committees may recommend approval or disapproval of a drug's marketing application. The FDA generally follows an advisory committee's recommendation, but it is not bound to do so.

The NDA for the proposed indication of NP, including ventilator-associated pneumonia, is based on data from the ATTAIN I and II clinical studies in adult patients. ATTAIN I and ATTAIN II were phase III, multicenter, double-blind, randomized clinical studies in which a total of 1,503 patients were enrolled and treated. Of these patients, 464 were infected with MRSA.

Patients with NP suspected or proven to be caused by Gram-positive bacteria were randomly assigned to receive either intravenous (IV) telavancin 10 mg/kg once daily or IV vancomycin 1 g every 12 hours. Aztreonam, piperacillin–tazobactam, and/or metronidazole were allowed for patients with suspected or proven polymicrobial infections involving Gram-negative and/or anaerobic bacteria in addition to the Gram-positive organisms for which the study medication was used. The objective of both studies was the non-inferiority of Vibativ versus vancomycin in the clinical cure rate at the test-of-cure visit. The determination of a clinical cure was based on physician-judged resolution of clinical signs and symptoms of NP. In both studies, the demonstration of non-inferiority was achieved in both the all-treated and the clinically evaluable patient populations.

Vibativ (telavancin) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action that allows it to inhibit bacterial cell-wall synthesis and to disrupt bacterial cell-membrane function. The drug is approved in the U.S. for the treatment of adult patients with complicated skin and skin structure infections (SSSIs) caused by susceptible isolates of Gram-positive bacteria, including S. aureus (both MRSA and MSSA).

Source: Theravance, Inc.; November 29, 2012.

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