FDA
1st April 2014

Tedizolid & Dalbavancin Both Unanimously Recommended by FDA Committee

Yesterday morning, the Anti-Infective Drugs Advisory Committee met to discuss new drug applications (NDAs) 205-435 and 205-436.

Tedizolid & Dalbavancin Both Unanimously Recommended by FDA Committee

Yesterday morning, the Anti-Infective Drugs Advisory Committee met to discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, for the proposed indication of treatment of acute bacterial skin and skin structure infections.

For this drug, there was one voting question with a follow-up discussion regarding the reasons for their vote, labeling recommendations, and additional studies recommended if the panelist voted no. The vote regarding whether the applicant had provided substantial evidence of the safety and effectiveness of tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections caused by susceptible isolates of the designated microorganisms resulted in 14 “yes” and 0 “no” votes.

This vote relied primarily on the results of two phase III randomized, active-controlled, double-blind, double dummy, multicenter, noninferiority studies (named “112″ and “113”) in which the comparator drug was linezolid (Zyvox). According to Anita Das, PhD, statistician speaking for the drug’s sponsor, tedizolid met the noninferiority criterion.

During the afternoon session yesterday, the committee discussed NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics, for the proposed indication of treatment of acute bacterial skin and skin structure infections.

For this drug, there was one voting question with a similar follow-up discussion. The vote regarding whether the applicant provided substantial evidence of the safety and effectiveness of dalbavancin for the treatment of acute bacterial skin and skin structure infections caused by susceptible isolates of the designated microorganisms resulted in 12 “yes” and 0 “no” votes.

This vote also relied primarily on two phase III noninferiority, double-blind, double-dummy, randomized trials (named “301” and “302”) which compared two weekly doses of dalbavancin with intravenous vancomycin. In both studies, dalbavancin met its primary endpoint of which was clinical response, defined as cessation of spread of the skin lesion and the absence of fever at 48 to 72 hours after study drug initiation, in the intent-to-treat (ITT) population.

The agency is not obligated to follow its committee’s recommendation, but normally does so.

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