Durata Therapeutics meets primary endpoints for EMA review in Phase 3 trial

theflyonthewall.com

Durata Therapeutics announced additional preliminary, top-line results for its DISCOVER 1 Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including MRSA. As reported on December 11, preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. The subpopulation of patients with MRSA at baseline achieved similar results. The secondary endpoint of clinical success at the end of treatment, the expected primary endpoint for regulatory review in Europe, was also met. Statistical analyses of the results from this secondary endpoint are included below in the updated table of top-line data.

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