GSK inflammation drug lands in COPD with new FDA nodding, intensifying competition with Sanofi Med
A GSK drug targeting the pathway behind lung inflammation in chronic obstructive pulmonary disease, or COPD, has won long-awaited FDA approval(Opens in new window)positioning biomedical to attract certain patients with debilitating respiratory diseases.
Regulatory approval announced Thursday covers the use of the drug Nucala as an additional maintenance therapy for adults who do not adequately control other therapies for COPD. The disease must also be characterized by a large number of eosinophils (a type of white blood cell).
In COPD, lung damage causes inflammation and dyspnea to worsen over time. It can be caused by smoking or other irritants in the lungs, which is why it is sometimes called the “smoker’s lung.” But for some patients, the driver of the disease is type 2 inflammation, an overimmune response of eosinophils. Nucala’s new approval covers this inflammation-driven treatment of COPD.
According to GSK, COPD has affected more than 390 million people worldwide. Type 2 inflammation is estimated to be present in up to 40% of these patients. Regardless of the type of inflammation that drives COPD, the condition can lead to worsening, and an attack of worsening symptoms usually requires hospitalization.
Standard COPD treatment includes older drugs such as bronchodilators and anti-inflammatory drugs. Biomedicine is becoming a new therapeutic option. Nucala is an antibody designed to block interleukin 5 (IL-5), a signaling protein that plays a role in the development of type 2 inflammation.
Nucala is used as a monthly subcutaneous injection and was approved by the FDA in 2015 as a treatment for severe asthma. Thursday’s approval was later than GlaxoSmithKline expected. The drug is scheduled to undergo regulatory decisions by May 7. This is after the resubmitted application. The drug giant initially nodded in search of COPD regulation seven years ago. In 2018, the FDA refused(Opens in new window) GSK’s application is designed to expand Nucala-approved uses to include COPD. The agency asked GSK to provide more clinical data.
In a new phase 3 clinical trial, GSK reported a clinically significant annual rate of 21% and a statistically significant 21% compared to placebo, achieving the primary goal of the test. In a post hoc analysis of patients with chronic bronchitis only, the drug resulted in a 31% reduction in the annualized rate of moderate/severe exacerbation versus placebo. Detailed results have been published(Opens in new window) Last month in the New England Journal of Medicine.
Recognizing all the warnings accompanying the cross-trial comparison, Nucala showed less aggravation reductions in Sanofi’s Dupixent achieved 30% and 34% reductions in its Pivotal COPD study. Last year Dupixent became the first biopharmaceutical to approve COPD driven by type 2 inflammation(Opens in new window). The Sanofi product will be Nucala’s most direct competitor.
Dupixent is an antibody designed to block the IL-3 and IL-4 pathways. The drug currently has seven signs of approval, with the FDA nodding in April in chronic spontaneous urticaria in inflammatory skin disease(Opens in new window). It is Sanofi’s best-selling product, accounting for 10.7 billion euros (about $11.6 billion) of revenue in 2024. Dupixent is given a subcutaneous injection every two weeks or every four weeks as directed. In COPD, which was added to the product label last year, was administered every two weeks.
GSK can inject nuclei in a single month with a smaller number of heavy nuclei, and can claim to have a dose advantage. The company can also point to the results of a major secondary trial target that shows a 35% reduction in annual growth in emergency medical visits and/or hospitalizations. But GSK also said that these results were “nominally significant” after adjusting for the increased likelihood of false positive results.
“In the United States, NUCARA approval provides an important option for patients with COPD,” Kaivan Khavandi, global head of respiratory, immunology and inflammation development at GSK, said in a prepared statement. “Long-term follow-up studies have shown that aggravation is the most important predictor of future risks, with results particularly poor in people who require hospital visits or admissions.”
GSK has been well established in respiratory diseases, with its highest therapy being Trelegy, an inhalation combination therapy approved for the treatment of COPD and asthma. The product accounts for £2.7 billion (about $3 billion) of COPD and asthma in 2024. NUCALA generates £1.7 billion (about $2.2 billion) in revenue(Opens in new window) Last year, all signs of approval for the product. In addition to severe asthma, Nucala’s approval involves nasal polyps, eosinophilic granulomas and polyvasculitis and hypereosinophilic syndrome.
Meanwhile, Sanofi’s pipeline also has another COPD candidate, an IL-33 blocking antibody called Itepekimab. Two phase 3 tests are underway in COPD; preliminary data are expected in the second half of this year. The phase 2 test of the drug is a treatment for airway inflammation in patients with COPD, and data is expected to be read in the second half of 2025.
Image: Jackie Niam, Getty Images
