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# ODAC Backs Emmaus’ Endari
- URL: https://www.fdaweb.com/odac-backs-emmaus-endari/
- Published: 2017-05-25T12:00:00.000Z
- Updated: 2026-09-14T22:25:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138785

The FDA Oncologic Drugs Advisory Committee has voted 10-3 to recommend that the overall risk/benefit profile of Emmaus Life Science’s Endari for treating sickle cell disease is favorable. The agency has a PDUFA target date of 7/7 to act on the company’s NDA.

If approved, Endari would be the first FDA-approved treatment for pediatric patients with sickle cell disease, and the first new treatment in almost 20 years for adult patients. The therapy is described as an orally-administered pharmaceutical grade L-glutamine.

Endari has received FDA orphan drug designation and fast track designation.