The U.S. FDA approved GSK’s Nucala (mepolizumab) for treating adult and pediatric patients with hypereosinophilic syndrome. Nucala is the first biologic approved for the eosinophilic driven disease and is the first product approved for HES patients in the last 14 years.
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The approval is based on the Phase 3 pivotal study, which demonstrated the efficacy of Nucala. The trial is a 32-week, randomized, double-blind, placebo-controlled study. 300 mg of Nucala was administered every four weeks, in patients aged 12 years and older. Reduction in HES flares was considered the primary endpoint; uncontrolled HES was defined as at least two HES flared in the past 12 months, and blood eosinophilic count is more than 1000 cells/µL. 50% of the patients experienced less HES glared in the Nucala arm compared to the placebo arm. 28% of patients on Nucala had fewer flares versus 56% of patients who were on the placebo group.
The overproduction of eosinophils characterizes hypereosinophilic syndrome, causing organ damage. Skin rashes, itching, asthma, difficulty breathing, abdominal pain, vomiting, arthritis, muscle inflammation, congestive heart failure, deep venous thrombosis, and anemia are the common symptoms of the diseases.
Nucala has received priority review from the U.S. FDA for HES.
Nucala acts by normalizing the eosinophils. The product prior approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
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