Fluticasone Propionate

GSK’s blockbuster respiratory drug Nucala has secured a China label expansion for certain patients with inflamed sinuses. But a more important challenge on the way to hitting its multibillion-dollar peak sales projections is on the horizon. Nucala could reach $2.35 billion in 2026 sales, according to GlobalData analysts. But this sky-high forecast is mainly driven by a potential new expansion in chronic obstructive pulmonary disease — the third leading cause of death worldwide. Late-stage data are still yet to be detailed, but a PDUFA date is set for May 7. On Friday, China’s NMPA greenlit the drug as an add-on to intranasal corticosteroids for people with chronic rhinosinusitis with nasal polyps (CRSwNP) that are inadequately controlled. The approval marks the third indication for Nucala in the country, following previous green lights for severe asthma and eosinophilic granulomatosis with polyangiitis. There are around 30 million people in China with CRSwNP, according to GSK. The latest approval gives them an alternative option to surgery and repeat use of oral corticosteroids, GSK’s head of respiratory and immunology R&D Kaivan Khavandi said in a release. Nucala is also approved for CRSwNP in the US, alongside other indications including severe asthma, hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis. The product reached £444 million ($550 million) in sales in the third quarter of 2024. While Nucala’s market expansion in China is welcome, the bigger commercial focus for GSK is COPD. In September, Nucala passed a Phase 3 test for the disease, which affects more than 390 million people worldwide. The drugmaker has yet to share details of the data publicly, but has already submitted them to the FDA. In December, CEO Emma Walmsley told investors at the Redburn Atlantic CEO Conference that Nucala could become “the first once-monthly biologic proven to reduce exacerbations across the full spectrum of COPD patients.” And “that’s important when you look at the competitive context here because we have included the most difficult-to-treat patients – those with emphysema, which I think is about a third of the market,” she added. Elsewhere, the company also has an ultra-long acting anti-IL-5 candidate, depemokimab, which is set to enter Phase 3 development for COPD this year. The drug has the potential to be efficacious when administered as little as once every six months, offering more convenience for patients.

FRIDAY, Jan. 3, 2025 -- For patients with chronic obstructive pulmonary disease (COPD), budesonide-glycopyrrolate-formoterol does not improve clinical outcomes compared with fluticasone-umeclidinium-vilanterol, according to a study published online Dec. 30 in The BMJ . William B. Feldman, M.D., M.P.H., from Brigham and Women's Hospital in Boston, and colleagues compared the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice-daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once-daily dry powder inhaler for treatment of COPD in routine clinical practice in a new-user, 1:1 propensity score-matched cohort study. The study included 20,388 propensity score-matched pairs of new users. The researchers found that the incidence of a first moderate or severe COPD exacerbation was higher in patients who received budesonide-glycopyrrolate-formoterol (hazard ratio, 1.09; 95 percent confidence interval, 1.04 to 1.14; number needed to harm, 38) compared with those who received fluticasone-umeclidinium-vilanterol, while the incidence of first admission to hospital with pneumonia was identical between the groups (hazard ratio, 1.00; 95 percent confidence interval, 0.19 to 1.10). Those receiving budesonide-glycopyrrolate-formoterol compared with fluticasone-umeclidinium-vilanterol had a higher risk for a first moderate COPD exacerbation (hazard ratio, 1.07; 95 percent confidence interval, 1.02 to 1.12 ; number needed to harm, 54) and for a first severe COPD exacerbation (hazard ratio, 1.29; 95 percent confidence interval, 1.12 to 1.48; number needed to harm, 97). Similar findings were seen in prespecified sensitivity analyses. "Our study may provide reassurance to health systems seeking to decrease greenhouse gas emissions by reducing use of metered dose inhalers, because the single-inhaler triple therapy with the lower carbon footprint (the dry powder inhaler, fluticasone-umeclidinium-vilanterol) was also associated with slightly improved clinical outcomes," the authors write. Several authors disclosed ties to the pharmaceutical and health information technology industries. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.