Emmaus Life Sciences Announces Submission of Marketing Authorization Application for Endari® to the Saudi Food & Drug Authority
TORRANCE, Calif., May 26, 2021 /PRNewswire/ -- Emmaus Life Sciences (Formerly Known As Emmaus Medical, Inc.), Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that its application for Marketing Authorization (MA) for Endari® in the Kingdom of Saudi Arabia has been accepted by the Saudi Food and Drug Authority (SFDA). The SFDA's MA review and approval process typically takes 12 to 18 months. Endari®, Emmaus' prescription grade L-glutamine oral powder, is approved by the United States Food and Drug Administration for treating sickle cell disease in adult and pediatric patients five years of age and older.
It is estimated that up to 1.4% of the total population of 35 million in the Kingdom of Saudi Arabia have sickle cell disease. During the SFDA's MA review and approval process, Endari® will be available to sickle cell disease patients on an early access basis to address an unmet medical need. Emmaus estimates that there are approximately 225,000 sickle cell disease patients that are reachable and could potentially be treated with Endari® throughout the Middle East and North Africa (MENA) region.
"This submission and acceptance of our marketing authorization application by the Saudi Food & Drug Authority is another significant step in our progress and commitment to serve sickle cell disease patients in the MENA region," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus.
George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added, "We look forward to continue building and enhancing our relationships with the hematologists and patient advocacy groups in the Kingdom of Saudi Arabia. Emmaus is also working with clinicians on providing Endari on a named-patient basis in the Kingdom and the wider MENA region."
About Emmaus Life Sciences
About Endari® (prescription grade 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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SOURCE Emmaus Life Sciences, Inc.
Company Codes: OtherOTC:EMMA, OTC-PINK:EMMA