FDA Approves First Drug to Treat Group of Rare Blood Disorders in Close to 14 Years |
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FDA Approves First Drug to Treat Group of Rare Blood Disorders in Close to 14 Years

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The U.S. Food and Drug Administration has approved mepolizumab for adults and children, 12 years of age and above, with hypereosinophilic syndrome (HES) for six months or longer, without any other identifiable non-blood related cause of the disease.

The new indication for the drug is the first approval for HES in around 14 years. This is the first time in over a decade that a new FDA-approved treatment option is available for patients with hypereosinophilic syndrome, stated Ann Farrell, M.D., director of the Division of Nonmalignant Hematology in the FDA’s Center for Drug Evaluation and Research.

A randomized, double-blind, multicenter, placebo-controlled trial assessed the drug in 108 patients with HES. Patients received mepolizumab or placebo by injection every four weeks and were compared for HES flare during the 32-week treatment period. Fewer patients in the mepolizumab group (28%) had HES flares compared to the placebo group (56%), with a 50% relative reduction… (FDA, September 25, 2020)

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