Emmaus Life Sciences submits New Drug Application for review of grade L-glutamine.
M2 PHARMA-November 10, 2016-Emmaus Life Sciences submits New Drug Application for review of grade L-glutamine
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United States-based Emmaus Life Sciences has submitted a New Drug Application for review of its orally administered pharmaceutical grade L-glutamine intended for the treatment of sickle cell disease, it was reported yesterday.
Data from the firm's Phase three sickle cell disease trial indicated a decrease in the frequency of sickle cell crises and hospitalisations, and a reduction in cumulative days hospitalised, and a lower incidence of the life-threatening acute chest syndrome.
The clinical trial enrolled 230 adult and paediatric patients from five years old, across 31 experienced sickle cell disease treatment centres in the United States. No major adverse events were attributable to the treatment. If approved, this indicates the first potential treatment for paediatric patients with sickle cell disease, and the first potential new treatment in around 20 years for adult patients.
The company is awaiting notice from the FDA regarding its request for a priority review. Emmaus' sickle cell disease therapy has Orphan Drug designation in the US, Orphan Medicinal Product designation in the EU and Fast Track designation from the FDA. Emmaus also plans to submit a marketing authorisation application to the European Medicines Agency.
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|Date:||Nov 10, 2016|
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