Will FDA ‘reboot’ antibiotic approval process?

At November hearing, FDA committee approves treatment for nosocomial pneumonia, sparking debate about agency’s approval of new antibiotics

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SILVER SPRING, Md.—With the number ofU.S. Food and Drug Administration (FDA) approvals of new antibioticsdeclining even as the incidence of drug-resistant bacteria strainsincrease, regulators and drugmakers recently debated clinical trialrequirements for antibiotics at a recent meeting of the FDA'sAnti-Infective Drugs Advisory Committee.

The meeting, held Nov. 29 in SilverSpring, Md., was called to discuss a new drug application (NDA) forTheraVance Inc.'s Vibativ (telavancin hydrochloride), a sterilepowder for injection. TheraVance is seeking approval of the drug forthe indication of nosocomial pneumonia (NP), includingventilator-associated pneumonia caused by susceptible isolates of thefollowing Gram-positive bacteria: Staphylococcus aureus(including methicillin-susceptible and resistant isoloates) orStreptococcus pneumoniae (penicillin-susceptible strains).

The meeting focused on whether clinicaltrial results for Vibativ provide substantial evidence of the safetyand effectiveness of telavancin for the treatment of nosocomialpneumonia when other alternatives are not suitable. TheraVance'spresentation focused on the increasing burden of NP due to known orsuspected MRSA. According to the company, more than 50 percent of S.aureus infections are MRSA and among the most common NPpathogens. Treatment of NP is increasingly difficult, and mortalityrates are on the rise, due to a paucity of current treatment optionsthat are also limited by emerging resistance and toxicity, thecompany testified.

FDA advisers did recommendapproval—after having previously rejected the drug because clinicaldata apparently did not meet the agency's guidelines. In 2010, theFDA requested evidence that patients were no more likely to diewithin 28 days of treatment with a new drug.

The approval has been pointed to bysome as a sign that the FDA may be relaxing its current approvalcriteria for antibiotics. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, recently said the agency islooking to "reboot" the antibiotic-approval process, and Congresslast summer passed a set of rules aiming to speed antibioticdevelopment.

"I've been very optimistic aboutthe whole thing," David Shlaes, head of Anti-Infectives Consultingin Stonington, Conn., told Nature. "But the FDA has to dosomething to show that it is actually rebooting."


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