TORRANCE, Calif., March 29, 2022 -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a leader in the treatment of sickle cell disease, announced today that the Florida Medicaid Pharmaceutical & Therapeutics Committee has approved adding Endari the company's prescription-grade L-glutamine oral powder for the treatment of sickle cell disease, to the Florida Medicaid Preferred Drug List ("PDL"), effective April 1, 2022. According to the Florida Agency for Health Care Administration ("AHCA") website, the PDL is a listing of cost-effective, safe and clinically efficient medication which can be prescribed without prior authorization documentation. However, clinicians retain the option of prescribing drugs not on the PDL.
"This approval from the Florida AHCA exemplifies their belief that Endari provides valuable clinical benefits to patients who are experiencing effects of their sickle cell disease and adds Florida to the many other states that have eliminated any prior authorization criteria," stated Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "This moves us another step closer to our goal of making Endari readily available to all professional health care providers and their sickle cell disease patients in need."
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. For more information, please visit www.emmausmedical.com.
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.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
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
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.1 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.2
1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020.
2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020.