FDA Approves Mepolizumab for Treatment of COPD Exacerbations
Approval comes from positive results in the MATINEE and METREX phase III trials, with data showing a significant reduction in annual rates of COPD exacerbations among patients.
GSK announced Thursday that mepolizumab (Nucala) has been approved by the FDA for the treatment of chronic obstructive pulmonary disease (COPD) exacerbations, according to a news release.1 Mepolizumab is now the only approved biologic option for the treatment of COPD studied in a wide-ranging population with eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL.
“The approval of Nucala in the US provides an important option for COPD patients. Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions,” said GSK’s Senior Vice President of Global Head, Respiratory, Immunology & Inflammation Research and Development Kaivan Khavandi. “Today, there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150 cells/μL who need new options like Nucala to support their treatment journey.”
COPD affects 16 million US patients and is 1 of the 10 leading causes of death. | image credit: photoopus / stock.adobe.com
COPD is a notably prevalent disease in the US, affecting nearly 16 million Americans, according to the CDC.2 It is 1 of the 10 leading causes of death in the US and it is often an undiagnosed disease, causing experts to believe many more than 16 million Americans have it. COPD is also a noncurable disease, opening up the door for products like mepolizumab to improve patient outcomes.
READ MORE: Pharmacists' Role in Helping Patients Manage COPD
Mepolizumab’s approval was based on data from the MATINEE and METREX phase 3 trials. Each trial was a randomized, double-blind, parallel-group design. The goal of these trials was to address the efficacy and safety of mepolizumab 100 mg as an add-on therapy to dual long-acting bronchodilators plus inhaled corticosteroid. Trial participants were administered mepolizumab every 4 weeks and matched with a placebo group.
“Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype,” wrote authors of the release.1 “Preventing exacerbations is a key goal of COPD management. Exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms, and increased mortality.”
Aside from the safety and efficacy of the drug, mepolizumab’s key function is to prevent COPD exacerbations or flare-ups, which are significantly common among people with COPD and can lead to a world of issues for them. These exacerbations can lead to a severe need for treatment using antibiotics, oral corticosteroids, or even hospitalization. And as lung function begins to decline in patients with COPD reaching older ages, flare-ups are only known to get worse.3
“Increasing frequency and severity of exacerbations are associated with increased rates of future exacerbations and mortality in primary care COPD patients. Interestingly, even one moderate exacerbation increased the rate of future exacerbations; however, it seems that patients with 3 or more moderate exacerbations are at a similar risk of future exacerbation compared to those with multiple severe exacerbations,” wrote the authors of a study published in the International Journal of Chronic Obstructive Pulmonary Disease.4
With the approval of mepolizumab, patients with COPD—as well as the subset of these patients with eosinophilic phenotype—now have viable options for managing both their COPD and the flare-ups that may accompany it.
“COPD isn’t just a disease, it’s a relentless cycle,” concluded Jean Wright, MD, MBA, CEO of the COPD Foundation, according to the release.1 “For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”
READ MORE: Respiratory Resource Center
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