Emmaus Life Sciences Receives Scientific Advice From the EMA Regarding Xyndari™
TORRANCE Calif., July 29, 2020 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today that the European Medicines Agency (EMA) issued scientific advice to Emmaus regarding the clinical development pathway for Xyndari™ for the treatment of sickle cell disease. Xyndari™ is the European brand name for the same Emmaus prescription product, Endari®, approved by the FDA and Israeli Ministry of Health.
The thoughtful and thorough feedback received during productive discussions with the Scientific Advice Working Party (SAWP) and the final written advice it received from the Committee for Medicinal Products for Human Use (CHMP) is greatly appreciated by Emmaus and will be very constructive in pursuing EMA approval for Xyndari™. Data from the FDA post-marketing commitment studies for Endari® will be presented to the SAWP when it becomes available. The EMA feedback regarding the emerging science and novel clinical study designs in the field of sickle cell disease drug development will assist Emmaus in optimizing the clinical studies for a future European Union (EU) marketing authorization application for Xyndari™.
Endari® is currently available to sickle cell disease patients in Europe on an early access basis only. It currently has a ten-year orphan drug designation (plus a two-year pediatric investigation plan) in the EU.
Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus, stated, “We are committed to the development and improvement in the treatment of sickle cell disease worldwide. As such, our goal is to bring Endari® and Xyndari™ to those who are in need as soon as possible.” Dr. Niihara commented further, “Emmaus is very appreciative of the guidance provided by the CHMP that will bring further credibility to the efficacy and safety of Xyndari™. We are also very grateful for the continued support of the FDA as Emmaus works on its post marketing commitment studies.”
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. For more information, please visit www.emmausmedical.com.
About Endari® (L-glutamine oral powder)
Important Safety Information
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
About Sickle Cell Disease
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