FDA's New Skin Infection Endpoint Needs Refinement, Advisory Panel Says
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.
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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.
Tedizolid, a next-generation antibiotic from the same class as Pfizer’s Zyvox, has met all complicated skin infection endpoints for both a U.S. and European filing, and Trius plans submissions in second half 2013 and first half 2014, respectively. European partnering talks, meanwhile, have gained new intensity.
FDA should provide more specificity on the non-inferiority margin it expects clinical trials for acute bacterial skin and skin structure infection (ABSSSI) treatments to satisfy, pharmaceutical companies and infectious disease specialists say.