Emmaus Life Sciences announced its submission, with request for Priority Review, to the Food and Drug Administration (FDA) a New Drug Application (NDA) for an orally administered pharmaceutical grade L-glutamine (PGLG) for the treatment of sickle cell disease in adults and pediatric patients.

The submission was supported by data from the Phase 3 trial of PGLG, which demonstrated a reduction in the frequency of sickle cell crises and hospitalizations in patients with the disease. Additionally, a reduction in cumulative days hospitalized and a lower incidence of life-threatening acute chest syndrome was also found in patients treated with PGLG. No major adverse events were observed in the study. 

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The FDA previously granted Orphan Drug and Fast Track designations to the Company’s orally administered pharmaceutical grade L-glutamine.

The NDA represents the first potential treatment for sickle cell disease in children and the first potential new treatment in nearly 20 years for adults.

For more information visit Emmausmedical.com.