GSK (NYSE: GSK) gets CHMP backing for Nucala in eosinophilic COPD after phase III data
Rhea-AI Filing Summary
GSK plc reported that the European Medicines Agency’s CHMP has issued a positive opinion recommending approval of Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils who are already on inhaled triple therapy. The opinion is based on the phase III MATINEE trial, where Nucala reduced the annual rate of moderate or severe COPD exacerbations versus placebo when both were added to triple therapy, with a rate ratio of 0.79 and similar overall adverse event rates between groups.
A pre-defined secondary analysis showed Nucala also lowered exacerbations that led to emergency department visits and/or hospitalisations compared with placebo. Nucala is already approved in Europe for four eosinophilic and type 2 inflammatory conditions and received US approval for COPD in May 2025. The European Commission decision on this new COPD indication is expected in Q1 2026, which could expand treatment options for patients whose disease remains uncontrolled.
Positive
- CHMP issues positive opinion for Nucala in eosinophilic COPD, supported by phase III MATINEE data showing reduced exacerbations on top of inhaled triple therapy.
- Potential EU label expansion into COPD would add to Nucala’s existing four European indications and follows its US COPD approval in May 2025.
Negative
- None.
Insights
CHMP backs Nucala for eosinophilic COPD, supporting a major new EU use.
The positive CHMP opinion for Nucala (mepolizumab) in eosinophilic COPD is an important regulatory step because it precedes a potential European Commission approval. The recommendation is supported by the phase III MATINEE trial, where mepolizumab reduced the annualised rate of moderate or severe exacerbations versus placebo on top of inhaled triple therapy, with a rate ratio of 0.79 and similar adverse event incidence.
The trial also showed a lower annualised rate of exacerbations requiring emergency department visits and/or hospitalisation, with a reported rate ratio of 0.65 for this secondary endpoint. COPD affects more than 40 million people in Europe, and a substantial subset have raised blood eosinophils despite triple therapy, so an add-on biologic option could be relevant for many of these patients if approved. The filing notes that the European Commission decision is expected in Q1 2026, which is the next regulatory milestone.
FAQ
What did GSK (GSK) announce about Nucala and COPD?
GSK announced that the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled COPD with raised blood eosinophils who are already receiving inhaled triple therapy.
What clinical data support Nucala’s COPD use for GSK (GSK)?
The recommendation is based on the phase III MATINEE trial, where mepolizumab plus inhaled triple therapy produced a statistically significant reduction in the annualised rate of moderate or severe COPD exacerbations versus placebo plus triple therapy, with a reported rate ratio of 0.79 and similar adverse event rates between arms.
How did Nucala affect severe COPD events like hospitalisations?
In a pre-defined secondary endpoint, Nucala reduced the annualised rate of COPD exacerbations requiring emergency department visits and/or hospitalisation compared with placebo, with a reported rate ratio of 0.65, indicating fewer severe exacerbation events in the mepolizumab group.
How large is the COPD population potentially relevant to GSK’s Nucala?
The disclosure notes that COPD affects more than 40 million people in Europe and more than 390 million globally, and estimates that over 35% of COPD patients inadequately controlled on inhaled triple therapy have raised blood eosinophils of at least 300 cells/µL, which is the type of population studied in MATINEE.
When is a regulatory decision expected on Nucala’s COPD indication in Europe?
The company states that the European Commission decision on approving Nucala for eosinophilic COPD is expected in Q1 2026, following the positive opinion from the EMA’s CHMP.
In which indications is Nucala already approved for GSK (GSK) in Europe and the US?
Nucala is already approved in Europe for severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It was also approved in the US for COPD in May 2025, making COPD its fifth indication there.
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