Breakthrough Clinical Results
The FDA approved GSK's Nucala (mepolizumab), an anti-IL-5 antibody, for the treatment of chronic obstructive pulmonary disease (COPD). This approval expands Nucala's indication beyond its previous uses in severe asthma and other inflammatory conditions. The approval follows successful results from the MATINEE and METREX clinical trials, demonstrating a significant reduction in COPD exacerbations. This positions GSK to compete with Sanofi and Regeneron's Dupixent, which also received approval for COPD in 2024. Nucala works by inhibiting IL-5, thus reducing inflammation in the lungs.
Key Highlights
- FDA approves Nucala for COPD expansion.
- Nucala shows significant reduction in COPD exacerbations in clinical trials.
- GSK will compete with Sanofi and Regeneron's Dupixent in the COPD market.
- Nucala is an anti-IL-5 antibody that works by reducing inflammation.
Drug used in other indications
Based on the provided context, there is no information available about:
- Nucala (mepolizumab) being trialled for indications other than Chronic Obstructive Pulmonary Disease (COPD)
- The intervention models for Nucala (mepolizumab) trials
The context does not contain any data about Nucala or mepolizumab clinical trials for any indication.
Incidence and Prevalence
Global Incidence and Prevalence of COPD
According to recent studies, Chronic Obstructive Pulmonary Disease (COPD) represents a significant global health burden with varying prevalence rates across different regions.
The World Health Organization predicts COPD will become the third leading cause of mortality and the fifth cause of disability in 2020 worldwide.
Regional Prevalence Data
Asia
- In rural southwest China, COPD prevalence increased from 8.7% to 12.8% between 2011 and 2021, with economic costs increasing 1.9-fold
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In India, the pooled prevalence of COPD among adults was 7.4% (95% confidence interval: 5.0%-9.8%) based on GOLD criteria and 11.9% (95% CI: 11.4%-13.6%) using LLN criteria
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Prevalence was higher among males, in urban areas, and in the northern region
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India contributes significantly to COPD mortality at 102.3/100,000 and 6,740,000 DALYs out of a world total of 27,756,000 DALYs
- In Chiang Mai, Thailand, the prevalence of COPD was 3.7% among the adult population studied
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In Bangladesh:
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The pooled COPD prevalence among Bangladeshi adults was 12.5% (95% CI, 10.9-14.1) using GOLD criteria and 11.9% (95% CI, 11.4-13.6) using LLN criteria
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Prevalence was higher among males, low socio-economic groups, rural residents, and biomass fuel users
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Another study reported COPD prevalence of 0.9% among 12,338 adults aged ≥35 years
Europe
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In Samara (Russia), COPD was found in 14.49% of 2,063 examined people
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Age-specific rates: 10.76% (30-39 years), 10.89% (40-49 years), 15.88% (50-59 years), and 21.30% (60+ years)
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COPD prevalence was 18.72% among men and 11.21% among women
Risk Factors and Demographic Patterns
Several demographic patterns emerge across these regional studies:
- Gender disparity: Males consistently show higher COPD prevalence across multiple countries
- Age correlation: Prevalence generally increases with age, as demonstrated in the Russian study
- Socioeconomic factors: Lower socioeconomic status correlates with higher COPD rates in some regions
- Rural vs. urban differences: Patterns vary by country, with some showing higher rural prevalence (Bangladesh) while others show higher urban prevalence (India)
- Environmental exposures: Biomass fuel use is identified as a risk factor in Bangladesh
These findings highlight the significant global burden of COPD with considerable regional variations in prevalence, suggesting the need for region-specific prevention and management strategies.