A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE β0-THALASSEMIA

Trial Profile

A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE β0-THALASSEMIA

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Glutamine (Primary)
  • Indications Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Emmaus Medical
  • Most Recent Events

    • 07 Jul 2017 According to a Food and Drug Administration media release, The U.S. Food and Drug Administration has approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.
    • 24 May 2017 According to anEmmaus Life Sciences media release, the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10 to 3 that the overall Benefit-Risk profile of L-glutamine [Endari; Emmaus Life Sciences] for the treatment of sickle cell disease (SCD) is favorable. The FDA has set a PDUFA target action date for July 7, 2017.
    • 18 Apr 2017 According to an Emmaus Life Sciences media release, the U.S. Food and Drug Administration (FDA) has set a date of May 24, 2017 to review the Company's New Drug Application (NDA) for its orally-administered pharmaceutical grade L-glutamine product (Endari™), for the treatment of sickle cell disease.
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