AstraZeneca's Fasenra Approved for Severe Asthma in Children 6-12

AstraZeneca has announced that its respiratory biologic, Fasenra (generic name: benralizumab injection), has received approval for a new indication in China. This approval allows Fasenra to be used for the maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to less than 12 years. The decision is based on the positive results from the global, multi-center, open-label Phase III clinical trial known as TATE. This trial was conducted in the United States and Japan and aimed to evaluate the pharmacokinetics, pharmacodynamics, and long-term safety of benralizumab in children aged 6 to 11 years with SEA.

The TATE trial demonstrated that benralizumab effectively reduced the frequency of asthma exacerbations in children with severe eosinophilic asthma. The drug was also found to be well-tolerated, with a safety profile consistent with that observed in adult patients. This new indication expands the use of Fasenra, which was previously approved for the treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older.

The approval of Fasenra for this new indication is a significant milestone for AstraZeneca, as it addresses an unmet medical need in the pediatric population. Severe eosinophilic asthma is a chronic inflammatory disease characterized by elevated levels of eosinophils, a type of white blood cell, in the airways. This condition can lead to frequent asthma exacerbations, reduced lung function, and a decreased quality of life. The availability of Fasenra for children with severe eosinophilic asthma provides a new treatment option that can help improve their symptoms and reduce the frequency of asthma attacks.

This approval underscores AstraZeneca's commitment to innovation and its dedication to improving the lives of patients. The company has been at the forefront of developing new treatments for respiratory diseases, and this approval further solidifies its position as a leader in the field. AstraZeneca's continued investment in research and development has led to the discovery of new therapies that address unmet medical needs and improve patient outcomes.

In summary, the approval of Fasenra for the maintenance treatment of severe eosinophilic asthma in children aged 6 to less than 12 years is a significant development in the field of respiratory medicine. This new indication provides a much-needed treatment option for children with this condition, and it highlights AstraZeneca's commitment to innovation and improving patient outcomes. The availability of Fasenra for this age group is expected to have a positive impact on the lives of children with severe eosinophilic asthma and their families.