Antibiotic Development Incentives Face Critical Test As NDA Reviews Begin
This article was originally published in Pharmaceutical Approvals Monthly
GAIN has encouraged FDA to be flexible on data requirements for antibiotics, according to sponsors.
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With two novel antibiotics approved and two more under review, 2014 is seeing the end of a long lean period for antibacterial R&D, helped by incentives like Qualified Infectious Disease Product designation. But only one candidate, Cubist’s ceftozolane/tazobactam, addresses the urgent need to target resistant Gram-negative bacteria.
BARDA’s Clinical Studies Network aims to reduce the number of countermeasure development failures.
A limited population antibacterial drug pathway could reassure investors about the viability of antibiotics and help FDA avoid looking over its shoulder as it approves products based on limited data, though enactment is uncertain.