Hypereosinophilic Syndrome (HES) Archives

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

Approvals, Eosinophils, FDA, FDA/Regulatory, Hypereosinophilic Syndrome (HES), Organ Damage, Rare blood diseases, White Blood Cells

The U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

FDA Approves Nucala as First Biologic Treatment for HES

Approvals, Biologics, Data, Eosinophilic Cells, Eosinophils, FDA/Regulatory, Hypereosinophilic Syndrome (HES), Rare Blood Disorders, White Blood Cells

The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause.

GSK’s Nucala Hits the Mark in Phase III HES Trial, Setting Up Potential Approval

Hypereosinophilic Syndrome (HES)

Two months after winning approval from the U.S. Food and Drug Administration as an asthma treatment, GlaxoSmithKline is eying another potential regulatory win for Nucala following positive Phase III results in the treatment of patients living with hypereosinophilic syndrome (HES).