CAPITAL – May 22, 2024 – The FDA has approved mepolizumab, branded as Nucala, as a new add-on treatment option for adult COPD patients. This long-awaited decision provides hope and relief. Who benefit from the new approved mepolizumab, with a focus on the treatment and management of COPD.
The Food and Drug Governance (FDA) has approved mepolizumab (Nucala) as a new maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) who are not adequately controlled and exhibit an eosinophilic phenotype. This is welcome news for patients and providers, offering an additional tool to combat the effects of COPD. The news is the result of extensive research and clinical trials,providing a new therapeutic avenue for the chronic respiratory disease.
FDA Approves Mepolizumab (Nucala) for COPD Treatment
Table of Contents
The Food and Drug Administration (FDA) has approved mepolizumab (Nucala; GSK) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disorder (COPD) who are not adequately controlled and exhibit an eosinophilic phenotype [[1]].
Clinical Trial Results
The approval is based on data from the MATINEE (NCT04133909) and METREX (NCT02105948) phase 3 trials. These trials demonstrated a notable reduction in the annualized rates of moderate or severe exacerbations with mepolizumab [[3]].
- MATINEE Trial: Assessed the efficacy and safety of mepolizumab for 52 to 104 weeks in 804 patients with COPD showing evidence of type 2 inflammation [[3]].
- METREX Trial: Evaluated the safety and efficacy of mepolizumab for 52 weeks in 836 patients [[3]].
In both trials, mepolizumab was administered at a dosage of 100 mg as add-on therapy, given subcutaneously every four weeks, compared with a placebo and optimal inhaled triple therapy [[3]].
Impact on COPD Exacerbations
Mepolizumab substantially reduced the annualized rate of moderate or severe exacerbations compared with the placebo in patients with an eosinophilic phenotype [[3]].
- In the MATINEE trial, the rate ratio (RR) was 0.79 (95% CI,0.66-0.94; P = .01) [[3]].
- In the METREX trial,the RR was 0.82 (95% CI, 0.68-0.98; adjusted P = .04) [[3]].
The secondary endpoint in MATINEE, which focused on the reduction in the annualized rate of COPD exacerbations requiring emergency department visits or hospitalization, showed a reduction in the mepolizumab group compared to the placebo (RR, 0.65; 95% CI, 0.43-0.96). However, this result was not statistically significant due to the failure of an earlier endpoint in the pre-specified hierarchical testing strategy [[3]].
Understanding COPD
COPD is a progressive, heterogeneous inflammatory lung disease characterized by persistent respiratory symptoms such as breathlessness, cough, and sputum, along with progressive airflow obstruction due to chronic inflammation [[3]]. These symptoms significantly impact daily quality of life, highlighting the need for advanced therapeutic options [[3]].
Standard treatment involves inhaled triple therapy.However, many patients continue to experience persistent and/or exacerbated symptoms, which can manifest as acute episodes of worsening COPD. In severe cases, COPD symptoms can led to hospitalization, irreversible lung damage, and mortality [[3]].
Mepolizumab: A targeted Approach
Mepolizumab is a monoclonal antibody that selectively targets and binds to interleukin-5 (IL-5), a key messenger protein responsible for type 2 inflammation. It is indeed designed to treat various IL-5-mediated diseases and has been approved in both Europe and the United States for multiple indications [[3]].
Expert Perspectives
COPD isn’t just a disease, it’s a relentless cycle,
said Dr. Jean Wright, CEO of the COPD Foundation. She added, 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.
[[3]]
According to Kaivan Khavandi, SVP, global head, Respiratory, Immunology & Inflammation R&D, GSK, The approval of Nucala in the US provides an crucial option for COPD patients. long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk,with notably poor outcomes in those requiring hospital visits or admissions.Today there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as [less than or equal to] 150 cells/μL who need new options like Nucala to support their treatment journey.
[[3]]
Ongoing Research
Ongoing clinical trials, such as MATINEE and COPD-HELP, will provide more data about the role of mepolizumab in treating COPD patients with eosinophilic inflammation [[2]].Mepolizumab could be a new therapeutic tool for eosinophilic COPD patients with frequent exacerbations despite optimal treatment and adequate control of comorbidities [[2]].
FAQ
- What is mepolizumab (Nucala)?
- Mepolizumab is a monoclonal antibody that targets interleukin-5 (IL-5), reducing inflammation in certain COPD patients.
- Who is mepolizumab for?
- It is for adult patients with COPD who have an eosinophilic phenotype and experience inadequately controlled symptoms.
- how is mepolizumab administered?
- It is administered subcutaneously every four weeks as an add-on therapy to existing treatments.
- what benefits have been shown in clinical trials?
- Clinical trials have demonstrated a reduction in the rate of moderate to severe COPD exacerbations.
