FDA: Targanta must conduct new oritavancin study

In a complete response letter the FDA informed Targanta Therapeutics that it will have to conduct another study of oritavancin, the company's experimental antibiotic for complicated skin and skin structure infections (cSSSI). The agency says trials of the drug predated the appearance of the most serious types of superbugs, causing experts to question data for these indications.

In its letter to Targanta, the FDA stated the Company's NDA did not demonstrate the safety and efficacy of oritavancin for treatment of cSSSI. The agency asked that in the next study, Targanta enroll more patients with methicillin-resistant Staphylococcus aureus (MRSA). They also "suggested" Targanta monitor macrophage function and phlebitis rates.

- see Targanta's release
- here's the AP article for more

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