GSK’s Nucala Wins FDA’s Approval for the Treatment of “Smoker’s Lung”

British drugmaker GSK PLC (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved its asthma drug Nucala as an add-on maintenance treatment for adult patients with inadequately controlled COPD (chronic obstructive pulmonary disease), or Smoker’s Lung, and an eosinophilic phenotype.

GSK’s Nucala Secures FDA’s Approval in COPD Indication

GSK disclosed that the FDA’s approval was based on data from the positive MATINEE and METREX phase III trials, in which Nucala (mepolizumab) displayed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations compared to the placebo in a “wide spectrum of COPD patients with an eosinophilic phenotype.”

Following this approval, GSK can now compete with Sanofi (SNY) and Regeneron Pharmaceutical’s (REGN) blockbuster drug Dupixent and Verona Pharma’s inhaled therapy Ohtuvayre, with both these treatments approved for Smoker’s Lung, which causes restricted airflow and breathing problems.

Interestingly, Nucala generated sales of 1.78 billion pounds ($2.38 billion) in 2024. The approval of this drug in another indication would further boost its sales, given that COPD is the fourth leading cause of death worldwide, according to the World Health Organization (WHO).

It is worth noting that the FDA had initially scheduled a target action date of May 7 for its decision on the drug. However, the regulatory body’s approval came two weeks later, after significant job cuts as part of a major overhaul of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr.

Is GSK Stock a Buy, Hold, or Sell?

Wall Street is currently sidelined on GSK stock, with a Hold consensus rating based on two Holds. The average GSK stock price target of $40.13 implies 3.1% upside potential.

See more GSK analyst ratings