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Pharmaceuticals / Submissions and Approvals

FDA Accepts Emmaus' New Drug Application for Sickle Cell Disease

Dec. 9, 2016
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The FDA has accepted for review the new drug application for its orally-administered pharmaceutical grade L-glutamine treatment for sickle cell disease.

The clinical trial enrolled 230 adult and pediatric patients as young as five years old, across 31 sickle cell disease treatment centers in the U.S.

The clinical data from the company's Phase 3 trial indicated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized and a lower incidence of the life-threatening acute chest syndrome.

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