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FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

pharmafile | September 28, 2020 | News story | Sales and Marketing  

The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES). 

This is specifically for patients 12 years and older who have had the condition for six months or more without a detectable non-haematologic secondary cause. 

This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. This took place over 32 weeks and found that 50% of patients demonstrated less HES flare when treated with Nucala compared to a placebo. 

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

Nucala was first approved in 2015 to treat severe eosinophilic asthma as an add-on maintenance therapy for the condition, and for the treatment of eosinophilic granulomatosis with polyangiitis. It also received approval in 2019 to treat severe eosinophilic asthma in children. 

HES is a rare disorder where patients have a persistent overproduction of eosinophils, a type of white blood cell, with levels that can reach three times higher than normal. When these particular white blood cells infiltrate certain tissues they can cause inflammation and organ damage which results in symptoms like fever and malaise, as well as respiratory and cardiac problems. If left untreated it can be life-threatening. 

Conor Kavanagh

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