A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, U.S. on August 14, 2012. (REUTERS/Jason Reed/File Photo)
WASHINGTON, July 7 (Xinhua) -- The U.S. Food and Drug Administration said Friday it has approved a drug called Endari to reduce severe complications associated with sickle cell disease in patients aged five years and older.
"Endari is the first treatment approved for patients with sickle cell disease in almost 20 years," Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, said in a statement.
"Until now, only one other drug was approved for patients living with this serious, debilitating condition."
In a randomized trial of patients aged five to 58 years old, those who treated with the drug had fewer hospital visits, fewer hospitalizations and fewer days in the hospital for sickle cell pain as well as fewer occurrences of acute chest syndrome, a life-threatening complication of this rare blood disorder, when compared to those who received a placebo.
Common side effects of the drug, produced by California-based Emmaus Medical, include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.
According to the U.S. National Institutes of Health, approximately 100,000 people in the United States have sickle cell disease. The average life expectancy for these patients is about 40 to 60 years.