Brief: Spero Therapeutics Receives Complete Response Letter From U.S. Food And Drug Administration For Tebipenem HBr New Drug Application

Spero Therapeutics

27/06/2022 21:47

June 27 (Reuters) - Spero Therapeutics Inc  SPRO.O :
    * SPERO THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM
U.S.
FOOD AND DRUG ADMINISTRATION FOR TEBIPENEM HBR NEW DRUG
APPLICATION
    * SPERO THERAPEUTICS INC - INTENDS TO PROMPTLY REQUEST A
TYPE A
MEETING WITH FDA
    * SPERO THERAPEUTICS - IN CRL, FDA COMMUNICATED THAT IT HAD
COMPLETED ITS REVIEW OF NDA AND DETERMINED THAT NDA COULD NOT BE
APPROVED IN ITS PRESENT FORM
    * SPERO - IN CRL, FDA ULTIMATELY CONCLUDED THAT CO'S PHASE 3
CUTI
STUDY OF TEBIPENEM HBR WAS INSUFFICIENT TO SUPPORT APPROVAL
    * SPERO THERAPEUTICS INC - TEBIPENEM HBR REMAINS AN
IMPORTANT PART
OF SPERO PIPELINE

Source text for Eikon:  ID:nGNX5T2bHD 
Further company coverage:  SPRO.O 

 ((Reuters.Briefs@thomsonreuters.com;))