FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair: Looking at the reviewer’s slides, there was really no question about the drug’s efficacy. Did tedizolid cure as many patients as linezolid? Yes, it did. Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority? Yes, they did. Trius even incorporated the latest revision of the Guidance – based on FNIH (Foundation of the National Institutes of Health) input – in its Phase 3 confirmatory 113 trial, i.e., lesion-size reduction. In most comparisons and subsets, the efficacy data for both drugs were pretty much superimposable.
Safety was also a home-run for tedizolid. GI adverse events were most common but the scrutiny was appropriately focused on neurologic and hematologic changes which did not raise flags of concern. So, the unanimous vote in support of tedizolid by all Ad Board members was justified and – anticipated.
Was this a trial run and check on the New Guidance, as issued in 2013? Was this meant to show that we now have a path to antibiotic approval that is feasible and science-based, validating the thought process which built on the placebo-controlled Snodberg trials from 1938? I am not sure what the Ad Board contributed and why it was needed. Overall, approx.. 50% of all NDA submissions go to an Ad Board, presumably to assist FDA in its review and to present problematic data and equivocal results to an independent outside expert panel for input. Not so here: this submission was as unproblematic as it gets.
Post Scriptum:
- On 6/22/2014 FDA approved Sivextro (tedizolid) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI).
- Cubist acquired Trius and Tedizolid / Sivextro July 30, 2013
