UK, US approve GSK's twice-yearly asthma drug

Regulators in the UK and US are the first to approve GSK's Exdensur, a long-acting, twice-yearly IL-5 inhibitor for severe asthma that has been billed as a major new product for the drugmaker.

In the UK – the first market for the drug – the MHRA has cleared Exdensur (depemokimab) for the treatment of asthma with type 2 inflammation, as well as for chronic rhinosinusitis with nasal polyps (CRSwNP). The verdict came shortly after Exdensur was also recommended for approval in the EU.

In the US, however, the FDA has approved Exdensur only for the severe asthma indication, as the agency declined to give a green light for the CRSwNP indication, without revealing its reasons. GSK told Reuters it remains confident that the drug has potential in CRSwNP and is "continuing discussions with the FDA."

The company is now waiting to hear from the regulatory authorities in other markets, including China and Japan, through the first half of 2026.

Specifically, Exdensur is approved in the UK as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype and whose symptoms can't be controlled with high doses of corticosteroids plus another asthma drug.

In CRSwNP, the label covers its use as an add-on to intranasal corticosteroids for adults with the condition for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.

GSK has said depemokimab is one of the top prospects in its pipeline, with peak sales potential of £3 billion ($3.7 billion) if approved across all its proposed indications, which also include eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic obstructive pulmonary disease (COPD).

Kaivan Khavandi, head of respiratory, immunology, and inflammation R&D at GSK, said Exdensur's first approvals have "the potential to redefine care for millions of patients."

The new drug is the successor to GSK's once-monthly IL-5 inhibitor Nucala (mepolizumab), which is also approved for severe asthma, CRSwNP and other indications, including COPD. Nucala generated £1.44 billion ($1.92 billion) in sales for GSK in the first nine months of this year.

It is a key growth prospect for GSK's new chief executive Luke Miels, who will take over from Emma Walmsley early next year.

Also this week, AstraZeneca's once-monthly TSLP inhibitor Tezspire (tezepelumab) was also approved for CRSwNP in the UK, having been cleared for this indication in the US and EU in October.