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2 个月前
BRIEF-Kamada to withdraw European Marketing Authorization application for inhaled ALPHA-1 antitrypsin
2017年6月22日 / 上午11点28分 / 2 个月前

BRIEF-Kamada to withdraw European Marketing Authorization application for inhaled ALPHA-1 antitrypsin

June 22 (Reuters) - Kamada Ltd

* Kamada announces withdrawal of European Marketing Authorization application for inhaled ALPHA-1 antitrypsin for treatment of ALPHA-1 antitrypsin deficiency disease

* Kamada Ltd -following discussions with EMA, Kamada concluded that EMA does not view data submitted to date as sufficient for approval of MAA

* Says Kamada intends to utilize data to be obtained from pivotal study to resubmit MAA to EMA

* Kamada - is currently in advanced discussions with U.S. FDA to secure approval of IND this year to conduct U.S. phase 3 pivotal study of inhaled AAT for treatment of AATD that would begin in 2018 Source text for Eikon: Further company coverage:

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