U.K. – Regulatory authorities in the EU, China, and Japan have begun evaluating GSK’s depemokimab, which aims to become the first drug for severe asthma that can be administered just twice a year.
The European Medicines Agency (EMA), along with counterparts in China and Japan, is reviewing the anti-IL-5 antibody as an add-on maintenance treatment for adults and adolescents aged 12 and over who have eosinophilic asthma.
This form of asthma is linked to type 2 inflammation and is difficult to manage with medium to high doses of corticosteroids in combination with other asthma medications.
At the same time, these regulators are also assessing depemokimab for another potential indication: as an add-on therapy for chronic rhinosinusitis with nasal polyps (CRSwNP).
GSK views depemokimab as one of its most promising pipeline drugs, projecting peak sales of £3 billion (US $3.7 billion) if it is approved for all its intended uses.
Kaivan Khavandi, GSK’s global head of respiratory and immunology R&D, expressed confidence in the drug’s potential, saying, “Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems.”
Depemokimab is positioned as a successor to GSK’s Nucala (mepolizumab), a monthly IL-5 inhibitor already approved for severe asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
Nucala generated £1.3 billion (US $1.6 billion) in sales during the first nine months of 2024, making it one of GSK’s top-performing products.
GSK’s 2025 launch pipeline includes five key products: Nucala for chronic obstructive pulmonary disorder (COPD), the novel antibiotic gepotidacin, a new meningitis vaccine (MenABCWY), and the relaunch of its cancer drug Blenrep (belantamab mafodotin).
In clinical trials, depemokimab demonstrated promising results in reducing severe asthma exacerbations.
In the SWIFT-1 and SWIFT-2 studies, it achieved a 72% reduction in clinically significant exacerbations that required hospitalization or an emergency room visit.
However, the drug did not meet expectations in other areas, including improvements in lung function, asthma symptoms, and quality of life over 52 weeks.
In the ANCHOR-1 and ANCHOR-2 trials for CRSwNP, depemokimab showed significant improvement in reducing nasal polyp size and nasal obstruction compared to a placebo over one year.
Additionally, GSK is running trials to assess the drug’s efficacy in treating EGPA (OCEAN trial) and HES (DESTINY trial).
Depending on the outcome of its Nucala filing for COPD, GSK may also explore depemokimab in COPD trials.