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BRIEF-Aeglea BioTherapeutics - Dialogue with FDA results in delay in initiating dosing in U.S. pediatric patients
May 23, 2017 / 12:12 PM / 7 months ago

BRIEF-Aeglea BioTherapeutics - Dialogue with FDA results in delay in initiating dosing in U.S. pediatric patients

May 23 (Reuters) - Aeglea Bio Therapeutics Inc

* Aeglea BioTherapeutics provides AEB1102 program and corporate update

* Aeglea BioTherapeutics -in march, received request from U.S.FDA that additional data may be needed to support inclusion of pediatric patients in phase 1/2 trial in arginase 1 deficiency

* Aeglea BioTherapeutics Inc - recently received written feedback from FDA based on supporting data provided in march and follow-up meeting with agency in late april

* Aeglea BioTherapeutics Inc - dialogue with FDA results in a delay in plan to initiate dosing in pediatric patients in united states

* Aeglea BioTherapeutics Inc -based on discussions with fda,unable to resolve difference in opinion at this time on data to support pediatric patients inclusion

* Aeglea BioTherapeutics Inc - “will continue to focus on our phase 1/2 trial, which we expect to begin enrolling adult patients in middle of 2017” Source text for Eikon: Further company coverage:

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