GSK plc revealed that the United States Food and Drug Administration (FDA) has begun the review process for data derived from the MATINEE study to potentially approve Nucala (mepolizumab) as an add-on maintenance therapy targeted at patients with eosinophilic chronic obstructive pulmonary disease (COPD). Based on the timeline provided by the Prescription Drug User Fee Act, the decision is expected by May 7, 2025.
The application relies heavily on findings from the MATINEE research, which assessed both the effectiveness and safety of mepolizumab among 804 COPD patients exhibiting type 2 inflammation, as indicated by elevated eosinophil counts. Participants in the study presented with diverse clinical manifestations, including challenging cases of emphysema, chronic bronchitis, or combinations of both conditions. The study demonstrated significant benefits by reducing the frequency of moderate to severe flare-ups compared to placebo over a treatment span of 52 to 104 weeks.
In the realm of type 2 inflammation, IL-5 acts as a pivotal cytokine, and around 40% of COPD patients are affected by it. This inflammation type can be identified through a simple blood test measuring eosinophil levels, which helps gauge the risk of exacerbations and the individual’s response to treatments.
Chronic obstructive pulmonary disease (COPD) affects over 390 million individuals globally, with more than 14 million cases identified in the U.S. The disease places huge demands on medical services, with recurrent exacerbations heavily impacting healthcare costs and contributing to approximately $7 billion in annual medical expenses in the U.S. alone.
The complete MATINEE trial outcomes will be shared at upcoming academic conferences, serving as a foundation for regulatory submissions worldwide.
Presently, Nucala is approved in the U.S. for addressing four conditions driven by IL-5. These include severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) for patients not adequately responding to nasal corticosteroids. Additionally, it is sanctioned for treating eosinophilic granulomatosis with polyangiitis (EGPA) and a specific form of hypereosinophilic syndrome (HES).
About COPD and Type 2 inflammation:
COPD is an advancing and varied inflammatory lung disease encapsulating chronic bronchitis and emphysema. It stands as the third highest cause of death globally, resulting in over 3 million annual fatalities. Patients frequently face enduring respiratory issues like shortness of breath, coughing, and mucus production, with exacerbations potentially leading to hospital admissions and irreversible lung damage.
Type 2 inflammation is noted in multiple immune-related conditions and serves as the root cause of symptoms and exacerbations for up to 40% of COPD sufferers. The presence of eosinophils in the bloodstream indicates this inflammation, which can be assessed through a straightforward blood test. IL-5, along with IL-4 and IL-13, comprises key cytokines in the inflammatory response, influencing more than just eosinophils; it can also affect other cellular types involved in inflammation and disease advancement.
Initially sanctioned in 2015 for severe eosinophilic asthma, mepolizumab binds to interleukin-5 (IL-5) and serves as a monoclonal antibody with targeted effects against type 2 inflammation. Nucala aims to tackle a variety of IL-5-mediated illnesses linked to this inflammatory pathway.
The focal trilogy of mepolizumab trials in COPD—including METREX and METREO, finalized in 2017, along with MATINEE—aimed to enhance understanding from earlier trials to identify patients most likely to benefit from Nucala for forthcoming approvals.
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