FDA Panel Says Arpida’s Iclaprim Inferior To Comparator
This article was originally published in The Pink Sheet Daily
Executive Summary
Advisory committee votes down the antibiotic based on the non-inferiority margin and problems with the clinical study and its results.
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More clinical data required for iclaprim application:
Arpida did not demonstrate efficacy of its anti-infective iclaprim for treatment of complicated skin and skin structure infections within an acceptable non-inferiority margin, FDA says in a "complete response" letter. An additional study showing non-inferiority of intravenous iclaprim to an approved comparator may be sufficient to meet this requirement, depending on study results, Arpida said Jan. 19. A resubmission will likely also provide updated safety data and labeling information. The letter was not a surprise, said CEO Jurgen Raths in a company release; a November advisory panel voted 17-2 against the drug's safety and efficacy (1"The Pink Sheet" DAILY, Nov. 20, 2008). Arpida slashed three-fourths of its workforce and will seek expert advice on further clinical development for iclaprim (2"The Pink Sheet," Dec. 22, 2008, In Brief)
More clinical data required for iclaprim application:
Arpida did not demonstrate efficacy of its anti-infective iclaprim for treatment of complicated skin and skin structure infections within an acceptable non-inferiority margin, FDA says in a "complete response" letter. An additional study showing non-inferiority of intravenous iclaprim to an approved comparator may be sufficient to meet this requirement, depending on study results, Arpida said Jan. 19. A resubmission will likely also provide updated safety data and labeling information. The letter was not a surprise, said CEO Jurgen Raths in a company release; a November advisory panel voted 17-2 against the drug's safety and efficacy (1"The Pink Sheet" DAILY, Nov. 20, 2008). Arpida slashed three-fourths of its workforce and will seek expert advice on further clinical development for iclaprim (2"The Pink Sheet," Dec. 22, 2008, In Brief)
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