MHRA Clears GSK’s Nucala for Eosinophilic COPD
The UK’s medicines regulator has authorised GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) of an eosinophilic phenotype who are already receiving triple inhaled therapy – an inhaled corticosteroid, a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
For patients whose symptoms and flare-ups continue despite the current standard of care, the decision opens the door to a new option designed to tackle the relentless cycle of exacerbations.
COPD remains a major pressure point for the United Kingdom health system, affecting an estimated three million people and driving a significant share of emergency hospital admissions. Exacerbations – the periods when symptoms suddenly worsen – account for a substantial proportion of the condition’s clinical and economic burden, with hospital admissions costing the NHS thousands of pounds per patient.
Beyond the numbers, these episodes can mean disrupted work, reduced independence, and repeated trips through urgent care pathways that few patients ever describe as “routine”, even when they become frequent.
The MHRA’s authorisation follows evidence from two placebo-controlled phase 3 studies, MATINEE and METREX. Across both trials, mepolizumab added to triple therapy achieved statistically significant reductions in exacerbation rates compared with placebo.
The studies also showed that treatment prolonged the median time to a first moderate or severe exacerbation once therapy had started – a meaningful outcome in a disease where preventing the next flare-up can be as important as treating the last one.
Clinicians have long highlighted how difficult it can be to keep exacerbations at bay for people living with COPD. The Director of King’s Centre for Lung Health and Chair of Respiratory Medicine at King’s College London noted that managing exacerbations is an ongoing challenge that significantly impacts patients’ lives, pointing to the reality that almost a quarter of hospitalised COPD patients are re-admitted within 30 days.
In that context, the approval of mepolizumab is framed as a new treatment option for eosinophilic COPD that can help reduce the frequency of exacerbations – potentially easing the clinical toll on individuals and the operational strain on hospitals.
From an industry perspective, GSK positioned the decision as part of a broader push to expand respiratory innovation. The company’s Medical Head, Specialty, GSK UK commented that the organisation is committed to redefining respiratory care through innovation.
Importantly, the pathway to widespread use will depend on health technology assessment: if recommended by the National Institute for Health and Care Excellence (NICE), mepolizumab would be administered every four weeks, with the aim of significantly reducing the rate of moderate/severe exacerbations and delaying the time to a first moderate/severe exacerbation once treatment begins.
On safety, the regulator’s decision reflected reassurance from the trial programme: the safety profile observed in MATINEE and METREX was consistent with what is already known for the medicine. For prescribers and patients weighing up escalation beyond inhaled therapies, that familiarity may matter, particularly when introducing a treatment intended for long-term maintenance rather than short-term rescue.
The next stage now shifts from authorisation to access. NICE and the Scottish Medicines Consortium will assess mepolizumab for reimbursement, a step that will determine how quickly – and how broadly – eligible patients across the UK can benefit from the new indication.
Conclusion
In authorising Nucala (mepolizumab) for adults with uncontrolled eosinophilic COPD already on triple therapy, the MHRA has signalled a notable expansion in the UK’s treatment landscape – one grounded in phase 3 evidence showing fewer moderate/severe exacerbations and more time before the next flare-up.
With COPD affecting around three million people nationwide and exacerbations driving both patient harm and costly hospital admissions, the focus now turns to NICE and the Scottish Medicines Consortium, whose reimbursement decisions will shape whether this new option becomes a practical reality in routine care.
News Credits: MHRA approves Nucala for eosinophilic COPD in adults on triple therapy
Things you may also like:
- Nulo Sets Its Sights on Britain’s Premium Pet Food Boom
- Genfit Flags Early Signs of Promise for GNS561 Combo for Cholangiocarcinoma
- NADMED Launches 2026 Award to Accelerate Redox Metabolomics Discoveries