Nucala Receives Expanded Indication

September 12, 2019 – The U.S. FDA has approved an expanded indication for Nucala® (mepolizumab), manufactured by GlaxoSmithKline. The product is now indicated for use as an add-on maintenance treatment for children who are at least six years of age and have severe eosinophilic asthma. It was previously approved only for children 12 years old and up.

Eosinophilic asthma is associated with high levels of white blood cells (eosinophils) and affects approximately 15% of the 25.7 million cases of asthma in the United States. It is characterized by recurrent exacerbations, poor disease control, and eosinophilic inflammation of the lungs. Nucala works by reducing the number of inflammation-causing eosinophils in the body.

In a clinical study, Nucala produced asthma relief for children from six through 11 years of age who had the eosinophilic phenotype. One-third of patients treated with Nucala experienced no asthma-related exacerbations during the study period. In an indirect treatment comparison of Nucala, FasenraTM (benralizumab – AstraZeneca), and Cinqair® (reslizumab – Teva), Nucala significantly reduced clinically significant exacerbations and improved asthma control compared to the other two products.

Recommended dosing is 40mg administered via subcutaneous (SC) injection once every four weeks for patients six through 12 years of age. For patients 12 years of age and up, the recommended dosing is 100mg administered via SC injection once every four weeks.

Nucala first received FDA approval in 2015, and is also indicated to treat adult patients who have eosinophilic granulomatosis with polyangiitis (EGPA).