Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency

Emmaus Life Sciences

19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines Agency for Xyndari (glutamine) for the treatment of sickle cell disease.

Xyndari was approved under the trade name Endari (L-glutamine oral powder) by the FDA to reduce the acute complications of sickle cell disease in adult and paediatric patients five years of age and older, based on the results of a Phase 3 study and other supportive studies. 

 Despite the results of the Phase 3 study and other data submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP), the CHMP maintains its initial opinion that the application did not demonstrate that Xyndari is effective at reducing the number of sickle cell disease crises or hospital visits.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier