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# NDA Accepted for Sickle Cell Treatment
- URL: https://www.fdaweb.com/nda-accepted-for-sickle-cell-treatment/
- Published: 2016-11-08T12:00:00.000Z
- Updated: 2026-09-14T21:46:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137283

FDA has accepted an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease. The submission is based on data from a Phase 3 study that 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, according to the company. It enrolled 230 adult and pediatric patients as young as five years old, across 31 sickle cell disease treatment centers in the U.S., and no major adverse events were attributable to the treatment, it says.