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The GlaxoSmithKline (GSK) antibody drug Nucala is not the first biologic to be approved for the treatment of nasal polyps, but it is the first IL-5 inhibitor to break through this indication, thus defeating competing products.
On Thursday, the US FDA approved Nucala for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP)
This approval marks Nucala's fourth approval for eosinophilic diseases
However, as the first IL-5 therapy approved in the disease, Nucala has further consolidated its advantage over Fasenra, which recently also lags behind Nucala in hypereosinophilic syndrome (HES)
The FDA's approval of Nucala to treat CRSwNP is based on the results of the SYNAPSE Phase 3 study
The results showed that during the 52-week treatment period, the number of patients requiring surgery in the Nucala group was 57% less than that in the placebo group
In terms of eosinophilic diseases, Nucala has previously been approved for 3 indications, including: treatment of adults and children (≥6 years old) with severe asthma with eosinophilic phenotype, treatment of eosinophilic granuloma with polyangiitis (EGPA) adults, treatment of eosinophilia syndrome (HES) adults and adolescents (≥12 years old)
According to the annual report released by GSK, Nucala broke the blockbuster threshold (US$1 billion) with sales of 994 million pounds (US$1.
As for AstraZeneca, Fasenra's sales in 2020 will be 949 million U.
At the same time, in the past few years, Nucala and Fasenra have been fighting fiercely in the eosinophilic asthma market
Reference source: GlaxoSmithKline's Nucala beats AZ's Fasenra to the IL-5 punch in nasal polyps