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Food and Drug Administration confirms new drug for sickle cell disease

The U.S. Food and Drug Administration on Friday approved the first new drug for sickle cell disease in nearly two decades.
(HealthDay News) — The U.S. Food and Drug Administration on Friday approved the first new drug for sickle cell disease in nearly two decades.
More informationThe U.S. National Heart, Lung, and Blood Institute has more on sickle cell disease.
Approximately 100,000 Americans, mostly minorities, have sickle cell disease, according to the U.S. National Institutes of Health.
Sickle cell disease is an inherited disorder in which the red blood cells are shaped like a sickle, which limits the flow of vital oxygen to organs and tissues.

as declared in

Food and Drug Administration confirms new drug for curing of sickle cell disease

“Endari is the first treatment approved for patients with sickle cell disease in almost 20 years.
Compounding the lack of viable, disease-ridding treatments is the fact that the Food & Drug Administration has not approved a new sickle-cell treatment drug in 20 years.
Prodigy, the late rapper who suffered from sickle-cell disease, played an important role in opening up dialogues about health in communities of color.
But, when the complications arise, we have very few tools specific to sickle cell to offer patients,” he explains.
According to the National Heart, Lung, and Blood Institute, one out of every 365 African-American babies is born with sickle-cell disease.
FDA approves new treatment for sickle cell disease

as declared in FDA approved on July 7 L-glutamine oral powder (Endari—Emmaus Medical) for patients aged 5 years and older with sickle cell disease to reduce severe complications associated with the condition.
Common adverse effects of L-glutamine oral powder include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain, and chest pain.
L-glutamine oral powder received Orphan Drug designation for this use.
A randomized trial of patients aged 5–58 years with sickle cell disease who had two or more painful crises in the year prior to enrollment was used to assess the safety and efficacy of L-glutamine oral powder.
“Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research and director of FDA’s Oncology Center of Excellence.

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