The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.
After failing to meet its target decision date earlier this month, the FDA on Thursday approved the expansion of GSK’s anti-IL-5 antibody Nucala to cover chronic obstructive pulmonary disease.
The approval opens up the use of Nucala to patients with a wider range of disease indicators. Nucala is indicated as an add-on treatment for these patients and should be used in the case of inadequately controlled disease, according to the updated label.
Nucala’s COPD approval is backed by the MATINEE and METREX trials. In September 2024, GSK announced that Nucala aced the MATINEE study, significantly and meaningfully reducing the annual rates of moderate or severe COPD exacerbations versus placebo for up to two years of follow-up. The pharma did not reveal specific data at the time, but GSK Chief Commercial Officer Luke Miels said during the company’s Q1 investor call in April that the company will share results from MATINEE “very soon.”
With Thursday’s label expansion, GSK steps up to challenge Sanofi and Regeneron, whose blockbuster biologic Dupixent won approval for COPD in September last year. At the time, however, the partners noted that Dupixent is indicated for patients with inadequately controlled COPD whose eosinophil counts are at least 300 cells/µL—a key disease indicator and a threshold twice as high as that now approved for Nucala.
“We’re looking forward to having fun with competing against Sanofi there,” Miels said during the earnings call.
Nucala is a subcutaneous IL-5 inhibitor that works by tamping down the inflammatory cascade, which in many diseases, such as COPD, is hyper-activated. The biologic was first approved in 2015 for severe asthma in patients ages 6 and up with an eosinophilic phenotype. Nucala has since picked up other inflammatory indications, such as chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Joining GSK, Sanofi and Regeneron in the COPD space is Verona Pharma, which in June 2024 won the FDA’s approval for Ohtuvayre, the first inhaled COPD drug.
