Emmaus Life Sciences Reports FDA Inspection Results of Postmarketing Compliance Program

Emmaus Life Sciences, Inc., based in Torrance, California, recently achieved a significant milestone. The biopharmaceutical company, recognized for its advancements in sickle cell disease treatment, was granted a "No Action Indicated" (NAI) classification after a routine inspection by the U.S. Food and Drug Administration (FDA). This classification reflects the company's adherence to postmarketing laws and regulations, ensuring the safety and efficacy of its products.

The inspection, which took place over two and a half days, was conducted by FDA Consumer Safety Officers. During the inspection, no objectionable conditions or practices were found in the six years since the company's product, Endari, has been on the market. Charles Stark, Pharm.D., Chief Scientific Officer of Emmaus Life Sciences, highlighted that based on a 2019 FDA inspection results survey, Emmaus falls within the top 16% of companies inspected that year. This underscores the company's commitment to maintaining high standards for its products, especially Endari® (L-glutamine oral powder), which is specifically designed for patients with sickle cell disease.

Dr. Stark attributed this achievement to the diligent efforts of Emmaus' Safety and Regulatory colleagues, Rafael Razon, M.D., and Rajani Singh, who have consistently ensured compliance with FDA regulations. Additionally, he expressed gratitude towards APCER Life Sciences, Emmaus' pharmacovigilance business partner, for their continued support.

Emmaus Life Sciences is a commercial-stage biopharmaceutical company that markets FDA-approved Endari® (L-glutamine oral powder). Endari® is intended to reduce the acute complications of sickle cell disease in individuals five years and older. Since its FDA approval in July 2017, Endari® has been available for sale in the United States starting in 2018. The medication helps alleviate the severe complications associated with sickle cell disease, such as pain crises and organ damage, by improving the flexibility and oxygen-carrying capacity of red blood cells.

The company is also involved in the research and development of new treatments and therapies for rare and orphan diseases, as well as conditions affecting larger populations, like diverticulosis. This ongoing commitment to innovation and patient care positions Emmaus Life Sciences as a leader in biopharmaceutical advancements.

Sickle cell disease (SCD) affects approximately 100,000 individuals in the United States and millions worldwide. The genetic mutation causing SCD leads to red blood cells adopting a sickle shape, impairing their ability to transport oxygen efficiently. These malformed cells can cause blockages in blood vessels, resulting in intense pain, tissue and organ damage, and reduced life expectancy. While SCD predominantly affects people of African descent, it is also present among various ethnic groups, including Hispanic Americans.

Emmaus Life Sciences estimates that around 225,000 individuals in the Middle East and North Africa region could benefit from Endari®. The company's efforts in addressing the needs of sickle cell disease patients globally highlight its dedication to improving patient outcomes and quality of life.

Emmaus Life Sciences continues to uphold its mission of delivering high-quality treatments and ensuring patient safety through rigorous compliance with regulatory standards. The recent FDA inspection results reinforce the company's role as a trusted provider in the biopharmaceutical industry, particularly for those affected by sickle cell disease.

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