Oncologic Drugs Advisory Committee recommends Endari (l-glutamine) to treat sickle cell disease.-Emmaus Life Sciences Inc.
Emmaus Life Sciences Inc. announced that the Oncologic Drugs Advisory Committee of the FDA voted 10 to 3 that the overall Benefit-Risk profile of Endari (l-glutamine) for the treatment of sickle cell disease (SCD) is favorable. The FDA has set a PDUFA target action date for July 7, 2017. If approved, Endari would be the first FDA-approved treatment for pediatric patients with SCD, and the first new treatment in almost 20 years for adult patients.
The therapy is an orally-administered pharmaceutical grade L-glutamine. If approved, Endari would be the first FDA-approved treatment for pediatric patients with SCD, and the first new treatment in almost 20 years for adult patients. The therapy is an orally-administered pharmaceutical grade L-glutamine.
Phase III results were modest, but the panelists hope that one new approval will convince drug development companies to pour more resources into sickle cell R&D.
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