September 12, 2017 / 11:08 AM / 2 months ago

BRIEF-Shire receives FDA fast track designation for SHP607

Sept 12 (Reuters) - Shire Plc

* SHIRE RECEIVES FDA FAST TRACK DESIGNATION FOR SHP607 FOR THE PREVENTION OF CHRONIC LUNG DISEASE IN EXTREMELY PREMATURE INFANTS

* ‍UNITED STATES FDA GRANTED FAST TRACK DESIGNATION FOR SHP607 FOR PREVENTION OF CHRONIC LUNG DISEASE IN EXTREMELY PREMATURE INFANTS​

* IS CURRENTLY CONDUCTING A FIVE-YEAR OBSERVATIONAL LONG-TERM OUTCOMES STUDY OF PATIENTS WHO HAD BEEN ENROLLED IN PHASE 2 STUDY.

* ‍FOLLOWING PHASE 2 STUDY RESULTS, INITIATED DISCUSSIONS WITH REGULATORY AUTHORITIES IN U.S, EUROPE AND JAPAN TO DISCUSS APPROPRIATE REGULATORY REVIEW PATHWAY FOR SHP607​

* PROCESS OF DEVELOPING A PHASE 2B/3 CLINICAL TRIAL SHP607 TARGETING A PRIMARY ENDPOINT FOCUSED ON CHRONIC LUNG DISEASE IN EXTREMELY PREMATURE INFANTS​ Source text for Eikon: Further company coverage:

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