08/02/2021 | Press release | Distributed by Public on 08/02/2021 10:16
Torrance CA, August 2, 2021 - Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in the treatment of sickle cell disease, announced today that Endari® has been included on the Preferred Drug List published on July 29, 2021, by Texas Health and Human Services (THHS). According to the THHS website, preferred drugs are medications recommended by the Texas Drug Utilization Review Board for their efficaciousness, clinical significance, cost effectiveness, and safety. The Texas Medicaid Formulary contains all products, including those on the preferred drug list, available to people enrolled in Medicaid. Preferred products are available without prior authorization, although they may be subject to clinical prior authorization.
With this recent revision, Texas joins many other states in improving access to Endari® for the treatment of sickle cell disease in Medicaid patients. Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older.
'We greatly appreciate that Texas Health and Human Services has eliminated the prior authorization criteria for Endari. This change, based on review and input from the Texas Drug Utilization Review Board, will afford health care providers and their sickle cell disease patients direct access to Endari,' said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. Dr. Niihara added, 'This is consistent with our goal is to make Endari readily available to patients throughout the country for whom it is indicated.'
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.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the potential impact of the addition of Endari® to the Preferred Drug List for Medicaid patients in Texas. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including uncertainties related to the future sales of Endari® in Texas and other states and other factors previously disclosed in the company's reports filed with the Securities and Exchange Commission, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law.
Emmaus Life Sciences, Inc.
Chief Operating Officer