Fda Approves Gsk’s Asthma Drug Nucala For Smoker’s Lung Treatment
Fda Approves Gsk’s Asthma Drug Nucala For Smoker’s Lung Treatment
GSK’s asthma drug, Nucala, has received FDA approval to treat ‘smoker’s lung,’ expanding its use as an add-on treatment for a type of chronic obstructive pulmonary disease (COPD). Nucala is a monoclonal antibody that inhibits interleukin-5, which regulates eosinophils—a white blood cell type that causes lung inflammation when overproduced.
‘Smoker’s lung’ primarily affects cigarette smokers but can also result from air pollution and occupational hazards. It is the fourth leading cause of death worldwide, according to the World Health Organization.
The FDA had set a target decision date of May 7 for Nucala, but approval came two weeks later. This delay follows a pattern of missed deadlines amid mass layoffs during a major overhaul of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr.
Approval was granted based on a late-stage trial where patients treated with Nucala plus an inhaled maintenance therapy for up to 104 weeks experienced a 21% reduction in exacerbations compared to placebo.
GSK’s Chief Commercial Officer, Luke Miels, said ahead of the approval, “There’s a very high burden when you have severe exacerbations and end up being hospitalized. The aim is to keep patients out of the hospital, keep them stable, and keep them at home.”
Nucala recorded £1.78 billion ($2.38 billion) in total sales last year.
