GSK's Mepolizumab (Nucala) Receives FDA Approval for Pediatric Eosinophilic Asthma in Children Aged 6–11

On September 17, 2019, VCBeat (WeChat ID: vcbeat) learned via Business Wire that British pharmaceutical giant GlaxoSmithKline (GSK) announced that its biologic drug mepolizumab (Nucala) had received FDA approval for the treatment of patients aged 6 to 11 years with eosinophilic asthma.

Mepolizumab was approved by the FDA for market launch in November 2015. It is the first anti-interleukin-5 (IL-5) monoclonal antibody approved globally and the first anti-IL-5 targeted biologic agent indicated for severe eosinophilic asthma. The drug prevents IL-5 from binding to receptors on the surface of eosinophils, thereby reducing eosinophil levels and lowering the risk of pneumonia.

Compared with similar drugs, mepolizumab demonstrates superior efficacy in the treatment of eosinophilic asthma. The drug has undergone multiple clinical trials involving over 3,000 patients and covering various eosinophilic indications to evaluate its safety and efficacy. One-year clinical trial data for mepolizumab indicate that pediatric patients receiving the treatment experienced effective disease remission. Furthermore, approximately one-third of the patients showed no disease exacerbation during the trial period.

Eosinophils are a type of white blood cell in the body that can release their cellular contents, causing tissue damage and promoting inflammation. Eosinophilia refers to an abnormally elevated level of eosinophils in the peripheral blood. Clinically, this condition is often associated with various disorders, particularly allergic diseases, parasitic infections, connective tissue diseases, and nonspecific tumor-related reactions.

Eosinophilic AsthmaEosinophilic asthma is a severe form of asthma characterized by recurrent exacerbations and poor control, with patients frequently exhibiting eosinophilic inflammation. Research has demonstrated that the proliferation, maturation, and activation of eosinophils are regulated by the cytokine IL-5.

Currently, mepolizumab has been marketed in 20 countries and regions, including the United States and Europe, as an add-on maintenance therapy for eosinophilic asthma. In addition, GSK is also evaluating the efficacy of this drug for other indications such as hypereosinophilic syndrome, nasal polyps, and chronic obstructive pulmonary disease (COPD).

GSK, founded in 1929 and headquartered in the UK, is a science-led global healthcare company. With over 10,000 employees, the company is dedicated to the research and development of innovative medicines, vaccines, and consumer health products. GSK’s mission is to discover new ways to prevent and treat diseases, thereby improving human health and quality of life while promoting the sustainable development of the healthcare industry.

Tonya Winders, Chief Scientific Officer and President of R&D at GSK, stated, “Eosinophilic asthma is difficult to cure completely, especially given the very limited treatment options for pediatric patients. Mepolizumab will bring hope to these patients and their families.”

(Compiled by Xu Xiaoxue)