CDC’s Antibiotic-Resistance Battle Plan Emphasizes Preserving Current Drugs
This article was originally published in The Pink Sheet Daily
Developing new drugs is only one of the four actions to prevent antibiotic resistance CDC calls for in a report that encourages “stewardship” of available therapies.
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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.
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
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.