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TORRANCE, Calif. - Emmaus Life Sciences, Inc. (OTCQB:EMMA), a biopharmaceutical company maintaining impressive gross profit margins of 93%, announced Thursday that the U.S. Food and Drug Administration has approved changes to the labeling of its sickle cell disease treatment Endari. According to InvestingPro data, the company generated revenue of $16.55 million in the last twelve months.
The updated label will include additional prescribing information based on post-marketing pharmacokinetic study data submitted by the company. According to the press release statement, the new information confirms dosing by body weight, demonstrates no unwanted accumulation through twice daily dosing, and indicates the medication can be administered with or without food. While the company faces challenges with cash burn and debt management, as highlighted by InvestingPro’s analysis, this regulatory milestone could be significant for its commercial operations.
Endari, a prescription-grade L-glutamine oral powder, is approved in the United States and other countries to reduce acute complications of sickle cell disease in patients five years of age and older.
Sickle cell disease affects approximately 100,000 people in the United States and millions globally. The genetic condition causes red blood cells to distort into a sickle shape, reducing oxygen transport throughout the body and leading to complications including severe pain, tissue and organ damage.
Common adverse reactions reported in clinical studies include constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
The safety and efficacy of Endari in children younger than five years has not been established, according to the company.
Emmaus Life Sciences describes itself as a commercial-stage biopharmaceutical company focused on treatments for rare and orphan diseases. InvestingPro analysis reveals additional insights about the company’s financial health and market performance, with 15+ exclusive ProTips available to subscribers, covering everything from valuation metrics to growth prospects.
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