Hamburg FDA May Look Favorably On Anti-infectives For Serious Conditions
Executive Summary
Anti-infective drug developers may see new opportunities for a favorable regulatory review climate for products for a few serious conditions, based on FDA's public health-oriented top management team under new Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein
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Antibiotic updates
The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)
Antibiotic updates
The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)
Commissioner Margaret Hamburg: Moving FDA Beyond A Regulatory Agency
Of the leading candidates for FDA commissioner in the Obama administration, Margaret Hamburg seemed among those with the least relevant experience - an illustrious career to be sure, but one that lacked a decision-making role involving medical products