ISLAMABAD: The U.S. Food and Drug Administration (FDA) has granted approval for Nucala, an asthma medication developed by British pharmaceutical company GlaxoSmithKline (GSK), to be used as an additional treatment for patients suffering from chronic obstructive pulmonary disease (COPD), often referred to as “smoker’s lung.” This decision was announced by GSK on Thursday, marking an expansion in the drug’s approved uses.
Nucala’s Mechanism and Clinical Trial Results
Nucala is a monoclonal antibody that targets interleukin-5, a protein involved in the regulation of eosinophils—white blood cells that cause lung inflammation when present in excessive amounts.
The approval was based on results from a late-stage clinical trial in which patients receiving Nucala alongside their regular inhaled maintenance therapy experienced a 21% reduction in disease exacerbations over 104 weeks, compared to those given a placebo.
These exacerbations often lead to hospitalizations, which the drug aims to reduce to improve patients’ quality of life.
Context and Market Position
Nucala joins other approved treatments for COPD, including Sanofi and Regeneron’s Dupixent and Verona Pharma’s inhaled therapy Ohtuvayre.
The chronic lung condition primarily affects smokers but can also result from exposure to air pollution and occupational hazards. According to the World Health Organization, COPD ranks as the fourth leading cause of death globally.
Despite the FDA missing its initially set target date for the approval, this decision is a significant development in the management of a disease with a high global burden.
Nucala generated sales worth £1.78 billion (approximately $2.38 billion) last year, underscoring its importance in respiratory medicine.
