> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Emmaus Files NDA for Sickle Cell Drug
- URL: https://www.fdaweb.com/emmaus-files-nda-for-sickle-cell-drug/
- Published: 2016-09-08T12:00:00.000Z
- Updated: 2026-09-14T21:30:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136731

Emmaus Life Sciences has submitted an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell disease. If approved, the drug would be the first treatment for pediatric patients, and the first potential new treatment in nearly 20 years for adults. Emmaus is requesting a priority review for the application.

Data from the company’s Phase 3 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 company says. The trial enrolled 230 adult and pediatric patients as young as five years old, across 31 experienced sickle cell disease treatment centers in the U.S. No major adverse events were reported with the treatment, it says.