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BRIEF-Achaogen says positive results in phase 3 trials of plazomicin
December 12, 2016 / 12:34 PM / a year ago

BRIEF-Achaogen says positive results in phase 3 trials of plazomicin

Dec 12 (Reuters) - Achaogen Inc

* Plazomicin well tolerated in both trials and shows improved overall safety compared with colistin in care trial

* Company plans to proceed with regulatory submissions in U.S. and Europe

* Epic registration trial successfully achieves FDA primary endpoints in patients with complicated urinary tract infections

* In addition, achaogen plans to publicly present detailed results from both Epic and Care trials in 2017

* Company also plans to submit a marketing authorization application (MAA) to EMA in 2018

* Epic demonstrates superiority on EMA primary endpoints

* Company plans to proceed with regulatory submissions in U.S. And europe

* Achaogen plans to submit a new drug application (NDA), which will include Epic and Care data, to FDA in second half of 2017

* Achaogen announces positive results in phase 3 CUTI and CRE clinical trials of plazomicin Source text for Eikon: Further company coverage: (Bangalore.newsroom@thomsonreuters.com)

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