GlaxoSmithKline's asthma drug Nucala expanded in US for use in younger children

GlaxoSmithKline said Thursday that the FDA expanded the label for Nucala (mepolizumab) to include children aged six to 11 years with severe eosinophilic asthma. The anti-IL5 therapy has been approved in the US since 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older.

Approval of the new indication was supported by an open-label study assessing the pharmacokinetics, pharmacodynamics and safety of Nucala in children aged six to 11 years with severe eosinophilic asthma. GlaxoSmithKline noted that 52-week data showed that the safety of Nucala in younger children was "similar to the known safety profile" in patients aged 12 years and older.

Chief scientific officer Hal Barron commented "children with severe eosinophilic asthma currently have limited treatment choices available to them," adding "we believe this important new indication for Nucala is a significant development for these children and their families."

European regulators cleared Nucala last year for use in children aged six to 17 years with severe refractory eosinophilic asthma. Meanwhile, self-administration options for Nucala were recently approved in the US and EU.

Sales of Nucala in the second quarter jumped 38% year-on-year to £195 million ($241 million) on continued global rollout of the therapy.  

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