FDA backs Merck's Zinplava to reduce recurrence of C. difficile infection
The US Food and Drug Administration on Friday approved pharma giant Merck & Co’s (NYSE: MRK) Biologics Licensing Application for Zinplava (bezlotoxumab) Injection 25mg/mL.
This is welcome news for Merck, given that back in July, the FDA requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending BLA for bezlotoxumab.
Merck anticipates making Zinplava available in first quarter 2017. As of late last year, the Thomson Reuters Cortellis database put the consensus forecast for 2020 global sales at $350 million. Merck licensed the drug from Medarex before the biotech firm was taken over by Bristol-Myers Squibb.
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