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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2019

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At a glance

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

    • 19 Sep 2019 According to a Emmaus medical media release, the marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari (glutamine) for the treatment of sickle cell disease has been withdrawn. The Committee for Medicinal Products for Human Use (CHMP) maintains its initial opinion that the MAA did not demonstrate that Xyndari is effective at reducing the number of sickle cell disease crises or hospital visits.
    • 29 May 2019 According to an Emmaus medical media release, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a negative opinion in relation to use of Xyndari (glutamine) in the treatment of sickle cell disease (SCD). The opinion is based on the CHMP's position that the main clinical study does not conclusively support the efficacy of the treatment on SCD patients, although no safety concerns were raised.
    • 04 Dec 2018 Results of an additional analysis assessing times to first and second crisis as well as cumulative recurrent events, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
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