GSK's Depemokimab Moves Toward FDA Approval in Asthma and Sinusitis

Depemokimab’s twice-yearly dosing and strong Phase III results could pave the way for approval in asthma and chronic rhinosinusitis.

GSK’s late-stage clinical data for depemokimab positions the drug for likely United States Food and Drug Administration approval in treating asthma and chronic rhinosinusitis with nasal polyps, as per insights shared by the Investigative News team at GlobalData, a leading data and analytics provider.

Depemokimab functions by targeting interleukin-5 to reduce inflammation caused by eosinophils and is delivered through a subcutaneous injection administered twice a year.

The drug has been evaluated in the pivotal Phase III SWIFT-1 and SWIFT-2 trials for asthma, as well as the ANCHOR-1 and ANCHOR-2 studies for chronic rhinosinusitis with nasal polyps. The results from these trials demonstrate both efficacy and safety that align with United States Food and Drug Administration’s approval criteria.

Quiz on Asthma
Introduction: Asthma is a chronic condition in which the airways become narrow and swollen and may produce extra mucus. This can lead to breathing difficulties and trigger coughing. Asthma can be mild sometimes, which ...

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Depemokimab may reach $1.65 billion in global sales by 2031, driven by its unique twice-a-year injection schedule and promising outcomes in both asthma and chronic rhinosinusitis. #asthma #biologics #medindia

Depemokimab's Competitive Advantage with Dosing Convenience

Twice-yearly administration of depemokimab is emerging as a potential advantage in a competitive biologics market. Although its efficacy is comparable to existing options like Dupixent and not necessarily superior, its ultra-long dosing interval could become a key differentiator in attracting patients and healthcare providers.

The Prescription Drug User Fee Act decision date for depemokimab in both asthma and chronic rhinosinusitis with nasal polyps is scheduled for December 16, 2025. With clinical trial outcomes meeting key safety and efficacy benchmarks, approval appears likely, though convenience of use may ultimately drive market uptake.

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Depemokimab Forecasted to Reach $1.65 Billion in Global Sales

GlobalData projects that depemokimab could generate $1.65 billion in global sales by 2031. A comprehensive breakdown of the available data, including the expected approval timeline and expert analysis of key events, is detailed in the “Catalyst Monitor Quarter Four 2025” report. This quarterly publication outlines 20 major regulatory and commercial events anticipated in the final quarter of 2025.

Additional high-profile catalysts in the report include United States Food and Drug Administration approval decisions for aficamten by Cytokinetics in hypertrophic cardiomyopathy and reproxalap by Aldeyra Therapeutics in dry eye disease, along with Sanofi’s tolebrutinib for primary progressive multiple sclerosis.

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Aficamten Shows Promise for Hypertrophic Cardiomyopathy Treatment

Cytokinetics’ aficamten has a Prescription Drug User Fee Act date set for December 26, 2025. The drug shows significant promise in treating hypertrophic cardiomyopathy, supported by clinical efficacy and notable improvements in patient quality of life. However, its pricing may lead some patients to opt for more affordable treatments like beta blockers or calcium channel blockers.

According to Irena Maragkou, Senior Healthcare Researcher at GlobalData, future treatment strategies for hypertrophic cardiomyopathy may move toward combination therapies, integrating myosin inhibitors, myosin modulators, and sodium glucose co-transporter inhibitors to enhance patient outcomes.

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Quarter Four 2025 Marks Pivotal Milestones for Drug Development

The Catalyst Monitor also features updates on other crucial assets such as Edgewise Therapeutics’ sevasemten for Duchenne muscular dystrophy and Pfizer’s brentuximab vedotin for diffuse large B-cell lymphoma. These additions further illustrate the significance of Quarter Four 2025 for regulatory milestones and commercial strategy within the pharmaceutical industry.

The Catalyst Monitor continues to serve as a vital resource for understanding the near-term landscape of drug development and regulatory events.
Source-Medindia