FDA to Review Oral Pharmaceutical Grade L-glutamine for Sickle Cell Disease
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.
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.