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Sidebar: Antibiotics: The Triumph Of Hope Over Experience?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Johnson & Johnson's swift exit from its collaboration with Basilea for Zevtera (ceftobiprole) is only the latest setback for the antibacterial field, which has had little success in producing NME approvals in recent years.

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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)

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals



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