GSK plc (GSK)'s Asthma Drug Gets FDA Nod to Treat 'Smoker's Lung'

The U.S. Food and Drug Administration has approved GSK plc (NYSE:GSK)'s asthma medication, Nucala, for expanded use in treating a form of chronic obstructive pulmonary disease (COPD), often referred to as “smoker’s lung,” the company announced Thursday.

This decision allows Nucala to be used as an add-on therapy for patients with a specific type of COPD. Nucala is a monoclonal antibody that targets interleukin-5, a protein involved in regulating eosinophils—white blood cells that can cause lung inflammation when present in excess.

Though the FDA had originally aimed to make a decision by May 7, the approval came two weeks later, continuing a trend of missed deadlines following recent staffing cuts and restructuring within federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr.

The green light was supported by results from a late-stage clinical trial showing that patients taking Nucala along with standard inhaled therapy experienced 21% fewer disease flare-ups over a 104-week period compared to those given a placebo.

In its press release, GSK plc (NYSE:GSK) highlighted that hospitalizations related to COPD are a growing burden on the healthcare system and could soon become the leading cause of medical admissions. Emergency room visits and inpatient treatments already represent a major share of the approximately $7 billion in annual COPD-related healthcare costs in the US.

GSK has surged by nearly 15% in 2025 so far.

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