Industry Insights Healthcare: 6/06/25
This week’s insights post discusses three of the most recent medication and device approvals in the healthcare industry.
FDA approves new drug for COPD associated with eosinophilic inflammation
The US Food and Drug Administration (FDA) has granted approval for GSK’s monoclonal antibody Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) characterised by eosinophilic inflammation. This approval marks the first biologic drug targeting eosinophilic COPD to receive regulatory approval in the US. A clinical trial recently published in the New England Journal of Medicine demonstrated that Nucala significantly reduced exacerbation rates in patients who experienced frequent and severe flare-ups. The approval reflects a growing trend toward phenotype-based management in respiratory diseases.
Handheld device promises to simplify COPD monitoring
Let’s stay with COPD for a bit longer. In a recent study published in Physiological Reports, researchers introduced a lightweight, portable device to assist with the daily monitoring of COPD patients. The so-called rapid expiratory occlusion monitor (REOM) uses electrical impedance spectroscopy to detect changes in lung functions. This device could potentially enable real-time monitoring outside of clinical settings. In initial testing, the device demonstrated a strong correlation with spirometry results in patients with mild (GOLD 1) COPD and those with severe (GOLD 4) disease. The results indicate REOM’s potential to reduce hospital visits and help doctors recognise the need for early intervention.
FDA approves first blood test for early Alzheimer’s diagnosis
The FDA has granted marketing authorisation to C2N Diagnostics for the PrecivityAD2™ blood test, which enables early detection of amyloid plaque build-up – a hallmark sign of Alzheimer’s disease. This test offers a minimally invasive and cost-effective alternative to traditional diagnostic methods such as PET scans or cerebrospinal fluid analyses. It measures biomarkers associated with amyloid pathology, thus providing clinicians with a quick tool for diagnosing patients with early cognitive decline. This approval can potentially contribute to early treatment of Alzheimer’s and improved patient outcomes.
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