GSK claims first approval for Nucala in COPD

GSK just hit one of its main objectives for 2025 after getting FDA approval of anti-IL-5 antibody Nucala as a treatment for chronic obstructive pulmonary disease (COPD).

Nucala (mepolizumab) has been cleared as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype in the US, which is the first world market for the new indication.

The drug is already used for asthma and various other conditions characterised by eosinophilic inflammation and is one of GSK's top sellers, with sales of nearly £1.8m billion ($2.4 billion) last year.

COPD is expected to be a major growth driver for the drug, however, given that it is the third leading cause of death worldwide and affects more than 300 million people globally, and GSK is modelling another £500 million a year from the COPD indication.

While not the first biologic to break into the COPD sector – Sanofi and Regeneron took that crown with the approval of their IL-2 and IL-13 inhibitor Dupixent (dupilumab) last year – GSK has high hopes for Nucala thanks to its less frequent dosing and the broader range of patients included in its clinical trials programme.

Specifically, GSK's drug is cleared for use in patients with a blood eosinophil count (BEC) of 150 cells/μL or higher, while Dupixent studies used a 300 cells/μL threshold. In a statement on the approval, GSK said that a lower threshold means that nearly 70% of COPD patients in the US who are inadequately controlled on inhaled triple therapy could be eligible for Nucala. It said that in the US alone, there are around a million people who could use Nucala as an add-on to their current treatment.

In addition, Nucala is administered once a month, while Dupixent needs to be taken every other week, in both cases using a pen-like autoinjector device.

The FDA approval was based on the MATINEE and METREX trials, which showed that Nucala was able to achieve a statistically significant reduction of around 21% in the annualised rate of moderate/severe exacerbations compared to placebo.

That came in lower than the 30% and 34% reductions seen in two pivotal trials of Dupixent, with the usual caveat of trying to compare results from studies with different protocols and patient populations.

Regulatory submissions for Nucala in COPD are currently under review in China and Europe.