12:00 AM
Dec 23, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Ceftolozane/tazobactam: Phase III data

Last month, Cubist reported that IV ceftolozane/tazobactam met the FDA- and EMA-defined primary endpoints of non-inferiority to IV levofloxacin in a pair of identical Phase III trials to treat complicated urinary tract infection (cUTI) (see BioCentury, Dec. 9). Cubist plans to submit an NDA to FDA in 1H14 and an MAA to EMA in 2H14 for ceftolozane/tazobactam to treat both cUTI and cIAI. Cubist also plans to start a Phase III trial with ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in 1H14.

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