The U.S. Food and Drug Administration (FDA) greenlit GlaxoSmithKline’s asthma drug Nucala (mepolizumab) nearly one year after the pharma giant posted data that showed it was a superior treatment in severe eosinophilic asthma in comparison to two other drugs in its class.

Late Thursday, GSK announced the FDA approved Nucala for use in children as young as six years old who are living with severe eosinophilic asthma. Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.

Nucala, which targets the IL-5 pathway, was initially approved in 2015 by the FDA to treat patients age 12 years and older with severe asthma with an eosinophilic phenotype. Severe eosinophilic asthma is a phenotype of severe asthma characterized by recurrent exacerbations, poor disease control and eosinophilic inflammation. Eosinophil proliferation, maturation, and activation are controlled by the cytokine interleukin 5 (IL-5). Nucala works by preventing interleukin-5 from binding to its receptor on the surface of eosinophil cells, a white blood cell that contributes to asthma. That interference reduces eosinophil levels. High levels of eosinophil can cause inflammation in the lungs.

Hal Barron, GSK’s chief scientific officer and head of research and development, called the FDA’s approval an important new indication for Nucala. He noted that children with severe eosinophilic asthma currently have limited treatment choices available to them.

The approval of Nucala for this indication is supported by strong data from a Phase III study conducted in children ages six to 11 who suffer from severe eosinophilic asthma. The year-long data showed that patients treated with Nucala experienced relief from the disease. The study also showed that the safety profile for Nucala remained consistent. Data from a late-stage trial showed one-third of patients treated with Nucala (mepolizumab) experienced no asthma-related exacerbations during the study. Also, last year, an indirect treatment comparison between Nucala and AstraZeneca’s Fasenra (benralizumab) and Teva Pharmaceuticals’ Cinqair (reslizumab) showed the GSK medication “significantly reduced clinically significant exacerbations and improved asthma control” compared to the other two branded products.

Nucala has been approved for use as an add-on treatment for severe eosinophilic asthma in patients aged six years and older in the EU since August 2018.

Tonya Winders, president and chief executive officer of the Allergy and Asthma Network, said that as a mother of children with asthma, she understands the worry about adequate treatments being available.

“Having Nucala approved as the first biologic for treating severe eosinophilic asthma in this young age group represents a significant step forward for the asthma community,” she said in a statement.

While Nucala has proven to be an important drug in the treatment of asthma, it has not fared so well with another pulmonary disease, chronic obstructive pulmonary disease, COPD.



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