United States
GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved its new twice-yearly injectable therapy for asthma, marking a significant advancement in the treatment of moderate-to-severe asthma.
The therapy, designed for patients whose symptoms are not adequately controlled by standard inhaled treatments, offers the convenience of just two injections per year while maintaining long-term asthma control. GSK’s clinical trials demonstrated that the therapy significantly reduced asthma exacerbations and improved lung function compared with existing standard-of-care therapies.
“This approval represents a major step forward in asthma management, giving patients a simple, effective option to help maintain control and reduce the burden of frequent medication,” said Emma Walmsley, CEO of GSK. “Our goal is to combine clinical innovation with patient convenience, and this therapy embodies that commitment.”
The FDA approval was based on data from pivotal Phase 3 studies that included adults and adolescents with moderate-to-severe asthma. Participants receiving the twice-yearly therapy experienced fewer hospitalizations and emergency interventions than those on standard therapy. The safety profile was consistent with expectations for biologic therapies in this patient population.
GSK plans to launch the therapy in the United States in early 2026, with access programs designed to ensure affordability for patients, including those with high-deductible insurance plans or limited coverage.
This approval underscores GSK’s ongoing investment in respiratory diseases and its commitment to innovative, patient-centric therapies. The company continues to explore new long-acting treatments for asthma and other respiratory conditions to improve outcomes and quality of life for patients worldwide.
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