Tedizolid, Dalbavancin Still Face Questions On ABSSSI Lesion Measurement
Both antibiotics gain a strong positive recommendation from FDA advisory committee, but questions about how skin lesions were measured before and during treatment persist as experience with new endpoint increases.
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Expedited pathways for acute bacterial infection treatments may increase number of new products at expense of safety and effectiveness, University of Washington doctors warn in JAMA Internal Medicine. Authors criticized trial designs used for Cubist’s Sivextro, Durata’s Dalvance and Theravance’s Vibativ.
The new endpoint proposed in FDA’s recent acute bacterial skin and skin structure infections guidance – cessation of lesion spread – needs further refinement to be a reliable assessment of antibiotic efficacy, according to members of the agency’s Anti-Infective Drugs Advisory Committee.
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials