TORRANCE, Calif. — Emmaus Life Sciences, Inc. (OTCQX: EMMA), a leader in sickle cell disease (SCD) treatment, today announced that it has received marketing authorization from the Puerto Rico Department of Health for Endari® (L-glutamine oral powder). This approval marks a significant milestone in Emmaus’ mission to improve the lives of people with SCD around the world and provides access to this important therapy for the patients living with SCD in Puerto Rico. In addition, Endari® is approved in the United States, Israel, United Arab Emirates, Kuwait, Qatar, Bahrain, and Oman.
“We are thrilled to bring Endari® to Puerto Rico, where the SCD community has faced significant challenges in accessing innovative treatments,” said George Sekulich, Co-President of Emmaus Life Sciences. “This approval is a testament to our commitment to working with regulatory authorities and patient advocacy groups to expand access to Endari® for all who need it.”
Endari® is the first FDA-approved oral glutamine therapy for the reduction of acute complications of SCD in adult and pediatric patients five years and older. Clinical studies have shown that Endari® can significantly reduce the frequency of pain crises, hospitalizations, and other acute complications of SCD.
Emmaus is committed to working with healthcare providers and payers in Puerto Rico to ensure that Endari® is accessible to all eligible patients. The company is also working to raise awareness of SCD and the benefits of Endari® through educational programs for healthcare providers and patients.
About Sickle Cell Disease
There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD. The genetic mutation responsible for SCD causes an individual’s red blood cells to distort into a “C” or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.
About Endari® (prescription grade L-glutamine oral powder) Indication
Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
About Emmaus Life Sciences
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.
Contact
Emmaus Life Sciences, Inc.
Willis Lee
Co-President and Chief Operating Officer
(310) 214-0065, Ext. 1130
[email protected]