FDA Approves New Treatment For Sickle Cell To Reduce Complications

(localmemphis.com) -  The FDA approved Friday a new treatment for sickle cell disease to reduce complications for patients age five and older.

It’s called Endari and it’s the first treatment approved for patients with sickle cell in almost 20 years. Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research Richard Pazdur is excited about the development.

“Until now, only one other drug was approved for patients living with this serious condition.”

Sickle Cell disease is an inherited blood disorder where the red blood cells are abnormally shaped. This restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage.

The FDA says Endari was studied in a random trial of patients from ages five to 58 years old with sickle cell disease who had more painful crises within a year before the trial.

The results showed that Endari decreased pain crises and chest complications. It also reduced hospital visits.  

The FDA says common side effects include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.

Approval of Endari was granted to Emmaus Medical Inc.

Approximately 100,000 people in the United States have sickle cell disease. The disease mainly affects African-Americans, Latinos and other minorities.


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