Emmaus Life Sciences Announces Withdrawal of Marketing Authorization Application to European Medicines Agency
EMMAUS LIFE SCIENCES INC (EMMA)
Company Research
Source: PR Newswire
TORRANCE, Calif., Sept. 19, 2019 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease treatment, today announced the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari™ (glutamine) for the treatment of sickle cell disease.Xyndari was approved under the tradename Endari® (L-glutamine oral powder) by the FDA to reduce the acute complications of sickle cell disease in adult and pediatric 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 MAA did not demonstrate that Xyndari is effective at reducing the number of sickle cell disease crises or hospital visits. "Because we have demonstrated the efficacy of Xyndari, as supported by the data from the trials condu
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