Emmaus Life Sciences Reinforces Positive Outcomes of Endari ® Clinical Trials, Including Efficacy Findings That Led to FDA Approval
EMMAUS LIFE SCIENCES INC (EMMA)
Company Research
Source: PR Newswire
TORRANCE, Calif., Sept. 24, 2019 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease (SCD) treatment, today released the following summary review of the clinical trials and efficacy findings for Endari®. "In light of our decision to withdraw our marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari™ (glutamine), there is some confusion relating to the previous clinical trials and efficacy findings that led to Endari's approval by the FDA in 2017," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "We appreciate the opportunity to provide the following summary to our shareholders and the SCD community." Endari Clinical Trial ResultsThe data supporting Endari® is straightforward, and the clinical trials leading to the therapeutic's approval by the FDA were a resounding success. The Phase 2 study results were a clear indicator of the efficacy of Endari® in preventing vaso-occlusi
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