UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra requires only a single subcutaneous injection monthly, contrasting with Nucala’s triple-shot monthly regimen, which is the current standard of care.
Implications of the Study Data for Regulatory Submissions
The data from this Phase III study will be utilized to support global regulatory submissions for Fasenra. This monoclonal antibody (mAb) is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) and is under development for other eosinophil-driven conditions, indicating its potential broad application in treating a range of diseases.
Fasenra’s Profile and Development Prospects
The positive results of the study not only reinforce Fasenra’s position as a competitive treatment option in EGPA but also contribute to its ongoing development for additional eosinophil-driven conditions. AstraZeneca’s commitment to advancing therapies for respiratory and immune-mediated diseases is further solidified with these promising results.-Fineline Info & Tech
