In 2015, the U.S. Food and Drug Administration (FDA) approved NUCALA (mepolizumab) for the treatment of severe eosinophilic asthma in adolescents and adults ages 12 and older, and by 2022, the FDA approved NUCALA for those between ages 6-11 years old.
Now, reports Pharmaceutical Technology, NUCALA is becoming available for more people globally living with eosinophilic asthma. China’s National Medical Products Administration (NMPA) recently approved NUCALA as an add-on maintenance therapy for people with severe eosinophilic asthma ages 12+.
NUCALA is a once-monthly injectable monoclonal antibody that targets an inflammatory signaling molecule called interleukin 5 (IL-5). IL-5 plays a role in activating eosinophils. By targeting IL-5, NUCALA aims to reduce inflammation and eosinophil presence.
The approval follows data from a Phase 3 clinical study. During the course of the study, researchers evaluated how safe NUCALA is, as well as how well it controlled the symptoms of severe asthma. Researchers found that NUCALA showed significant benefit in reducing asthma episodes when compared to a placebo. Further, people taking NUCALA were less likely to require hospitalization.
About Eosinophilic Asthma
Eosinophilic asthma is a rare and severe subtype of asthma that is associated with high levels of eosinophils (a type of white blood cell) in the mucus, lung tissue, and blood. This form is most common in adults between ages 35-50, though it can happen in people of other ages. Unlike other forms of asthma, eosinophilic asthma can be more difficult to control. Inhaled and oral corticosteroids are used for treatment. Some individuals may see better responses when using biologics like dupilumab, mepolizumab, benralizumab, or reslizumab.
Eosinophilic asthma causes inflammation that makes it harder to breathe. People with this form of asthma are also more likely to develop chronic rhinosinusitis and nasal polyposis. Symptoms relating to eosinophilic asthma may include reduced lung function, chest tightness, coughing and/or wheezing, difficulty breathing, loss of smell, and nasal drainage or a stuffy nose.
