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FDA Alerts
Hematology
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FDA approves treatment for hypereosinophilic syndrome

Posted on September 28, 2020

The U.S. Food and Drug Administration has approved mepolizumab (Nucala; GlaxoSmithKline) for the treatment of patients with hypereosinophilic syndrome (HES) for ≥ 6 months without an identifiable non-hematologic secondary cause. This is the first targeted biologic treatment for patients with this eosinophil-driven disease in the United States.

Approval was based on data from a pivotal phase 3 study which showed 50% fewer patients experienced a HES flare when mepolizumab was added to standard of care treatment, compared to placebo, over the 32-week study period (28% vs 56%; P = 0.002).

“HES is a complex, life-threatening condition that impacts nearly 5,000 patients in the US. Today’s approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases,” said Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, in a statement.

Read the full press release here.

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