The Food and Drug Administration on July 7 approved Emmaus Medical's drug Endari to treat serious complications associated with sickle cell disease, marking the first sickle treatment approval in nearly two decades.
Patients with sickle cell disease have abnormally shaped red blood cells, which can hinder blood flow and limit oxygen delivery to the body. Recent clinical trials showed patients taking Endari had fewer hospital visits and shorter length of stays for sickle cell complications than those taking a placebo.
"Until now, only one other drug was approved for patients living with this serious, debilitating condition," said Richard Pazdur, MD, acting director of the FDA's Office of
Hematology and Oncology Products and director of the agency's Oncology Center of Excellence.
Emmaus Medical did not say when Endari will hit the market.
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