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Will FDA ‘reboot’ antibiotic approval process?
January 2013
by Amy Swinderman  |  Email the author


SILVER SPRING, Md.—With the number of U.S. Food and Drug Administration (FDA) approvals of new antibiotics declining even as the incidence of drug-resistant bacteria strains increase, regulators and drugmakers recently debated clinical trial requirements for antibiotics at a recent meeting of the FDA's Anti-Infective Drugs Advisory Committee.

The meeting, held Nov. 29 in Silver Spring, Md., was called to discuss a new drug application (NDA) for TheraVance Inc.'s Vibativ (telavancin hydrochloride), a sterile powder for injection. TheraVance is seeking approval of the drug for the indication of nosocomial pneumonia (NP), including ventilator-associated pneumonia caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and resistant isoloates) or Streptococcus pneumoniae (penicillin-susceptible strains).

The meeting focused on whether clinical trial results for Vibativ provide substantial evidence of the safety and effectiveness of telavancin for the treatment of nosocomial pneumonia when other alternatives are not suitable. TheraVance's presentation focused on the increasing burden of NP due to known or suspected MRSA. According to the company, more than 50 percent of S. aureus infections are MRSA and among the most common NP pathogens. Treatment of NP is increasingly difficult, and mortality rates are on the rise, due to a paucity of current treatment options that are also limited by emerging resistance and toxicity, the company testified.

FDA advisers did recommend approval—after having previously rejected the drug because clinical data apparently did not meet the agency's guidelines. In 2010, the FDA requested evidence that patients were no more likely to die within 28 days of treatment with a new drug.

The approval has been pointed to by some as a sign that the FDA may be relaxing its current approval criteria for antibiotics. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, recently said the agency is looking to "reboot" the antibiotic-approval process, and Congress last summer passed a set of rules aiming to speed antibiotic development.

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

Code: E011325



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