PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This marks a major milestone, offering a new treatment option for individuals whose condition remains inadequately controlled despite inhaled triple therapy.
Nucala is the first and only biologic approved for a broad population of COPD patients with blood eosinophil counts (BEC) starting at 150 cells/µL. The approval is based on robust clinical data from the MATINEE and METREX Phase III trials, which demonstrated a statistically significant reduction in moderate and severe exacerbations compared to placebo. Notably, exacerbations are a leading cause of lung damage, worsening symptoms, and mortality in COPD patients.
“The approval of Nucala in the US provides an important option for COPD patients,” said Kaivan Khavandi, Senior Vice President, Respiratory, Immunology & Inflammation R&D, GSK. “Exacerbations are the single most important predictor of future risk, particularly for those requiring hospitalization. Today, we offer hope for improved care for patients with an eosinophilic phenotype, including those with a BEC of 150 cells/µL or higher.”
Approximately 70% of COPD patients in the US inadequately controlled on inhaled triple therapy have a BEC within the eligible range, representing more than one million individuals who may benefit from Nucala.
Jean Wright, CEO of the COPD Foundation, emphasized the potential impact of this treatment. “COPD isn’t just a disease; it’s a relentless cycle,” she said. “Managing exacerbations is a significant challenge for patients, even with existing therapies. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”
The two large-scale trials, MATINEE and METREX, evaluated Nucala’s efficacy and safety. MATINEE’s data showed a 21% reduction in moderate to severe exacerbations and a 35% reduction in exacerbations requiring emergency department visits or hospitalization. METREX provided further validation of the therapy’s effectiveness in a wide spectrum of COPD patients with eosinophilic inflammation.
COPD affects over 14 million people in the US and leads to significant healthcare burdens, including more than 300,000 hospitalizations annually. GSK’s Nucala offers a promising pathway to help reduce the frequency and severity of exacerbations, improving outcomes for a population with few existing options.
The approval positions Nucala as a pivotal innovation for patients with eosinophilic COPD, ushering in a new era of targeted treatment for this complex condition.
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