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Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow

 
• By Brenda Sandburg

Merck rejected FDA's recommended endpoint to show efficacy in preventing C. difficile recurrence, which could make it difficult to gain approval for the product, headed to June 9 advisory panel review.

Merck & Co. Inc. chose not to use FDA's recommended primary endpoint for bezlotoxumab, a decision that could impede approval of the monoclonal antibody for prevention of Clostridium difficile infection (CDI) recurrence, a briefing document for an upcoming advisory committee review suggests. The agency says the clinical trial endpoint Merck used is difficult to interpret and may not show efficacy.

"While there appears to be a decrease in CDI recurrence with the use of bezlotoxumab, there is concern as to...

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