The FDA rejected the use of Exdensur, however, for chronic rhinosinusitis with nasal polyps.
The FDA has approved GSK’s anti-IL-5 antibody depemokimab for the treatment of severe eosinophilic asthma in patients 12 and older. The drug will carry the brand name Exdensur.
Exdensur is indicated as an add-on or maintenance therapy and is administered via a subcutaneous injection every six months, according to its label. It is an ultra-long-acting biologic that allows for twice-yearly dosing in asthma, GSK said in its news release on Tuesday.
Data from the Phase III SWIFT-1 and SWIFT-2 trials supported Exdensur’s approval. Results, published in the New England Journal of Medicine in September 2024 showed a 58% drop in the rate of annualized asthma exacerbations in the former study, whereas treatment effect in the latter trial reached 48%.
Exdensur also numerically lowered exacerbations leading to hospitalizations and/or emergency visits across both SWIFT studies. The drug was likewise well-tolerated in the late-stage program, with comparable rates and severity of adverse events between the treatment and placebo arms.
“Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma,” Kaivan Khavandi, global head of Respiratory, Immunology and Inflammation R&D at GSK, said in a statement. Exdensur, he added, “could redefine patient care” in this indication.
Exdensur blocks a key molecule—the IL-5 cytokine—involved in the differentiation, growth, activation and survival of eosinophils, a type of white blood cell involved in inflammation. This mechanism of action allows Exdensur to address an underlying pathological mechanism in asthma.
Aside from asthma, however, GSK was also hoping to use Exdensur for chronic rhinosinusitis with nasal polyps (CRSwNP). The FDA did not grant this approval, according to a Tuesday report from Reuters. GSK will continue to engage with the regulator on gaining approval in the indication, a spokesperson said.
Exdensur’s CRSwNP package included data from the late-stage ANCHOR-1 and ANCHOR-2 trials, which showed significant improvements in nasal polyp scores and mean nasal obstruction versus placebo. The U.K.’s Medicines and Healthcare Products Regulatory Agency on Monday approved Exdensur for both asthma and CRSwNP.
GSK is continuing to test Exdensur for other inflammatory conditions, including chronic obstructive pulmonary disease, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome, all of which are in late-stage development.
