Priority Review for Cubist's tedizolid

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) said FDA accepted and granted Priority Review to an NDA for tedizolid to treat acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date is June 20. The NDA covers IV and oral formulations of tedizolid, which both have Qualified Infectious Disease Product (QIDP) designation from FDA to treat ABSSSI and hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). The designations make the antibiotic eligible for an additional five years of market exclusivity, if approved.

In 1H14, Cubist plans to submit an MAA to EMA and an NDS to Health Canada for tedizolid for ABSSSI. The company gained the second generation oxazolidinone, a bacterial protein biosynthesis inhibitor, through its September acquisition of Trius Therapeutics Inc. (see BioCentury, Aug. 5). ...