Emmaus Life Sciences Inc., files NDA at FDA for L-glutamine treatment for Sickle Cell Disease.

Emmaus Life Sciences, Inc., announced it has submitted a New Drug Application (NDA) to the FDA requesting U.S. marketing approval for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease. The NDA represents the first potential treatment for pediatric patients with sickle cell disease, and the first potential new treatment in nearly 20 years for adult patients. Emmaus is requesting Priority Review of the application.

Data from the Company�s Phase III sickle cell disease trial demonstrated 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. The clinical trial enrolled 230 adult and pediatric patients as young as five years old, across 31 experienced sickle cell disease treatment centers in the United States. No major adverse events were attributable to the treatment.

Comment: Emmaus� sickle cell disease therapy has Orphan Drug designation in the U.S. and Europe and Fast Track designation from the FDA. Emmaus also plans to submit a marketing authorization application to the European Medicines Agency.