GSK announced that the European Commission has approved Exdensur (depemokimab) as an add-on therapy for two indications: severe asthma with type 2 inflammation in adults and adolescents 12 years and older inadequately controlled despite high dose inhaled corticosteroids plus another asthma controller, and severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults for whom systemic corticosteroids and/or surgery do not provide adequate control.

The approval is supported by four Phase 3 trials, including the SWIFT and ANCHOR programmes, which demonstrated statistically significant and clinically meaningful outcomes for both diseases. Exdensur, administered twice yearly, is the first ultra-long-acting biologic in Europe for these respiratory conditions, combining high interleukin-5 binding affinity and potency with an extended half-life.

Kaivan Khavandi, svp, global head, respiratory, immunology & inflammation r&d, GSK, said: “The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.”

In SWIFT-1 and SWIFT-2 trials, depemokimab reduced the annualised rate of asthma exacerbations by 58% and 48% respectively, with fewer hospitalisations or emergency visits compared with placebo. ANCHOR-1 and ANCHOR-2 trials showed improvements in nasal polyp score and nasal obstruction verbal response scale over 52 weeks. Across these trials, depemokimab was well tolerated, with side effects comparable to placebo.

Stephanie Korn, md, head of the clinical research centre ikf pneumologie Mainz, said: “People living with the burden of severe asthma face persistent exacerbations driven by uncontrolled type 2 inflammation. A new option with twice-yearly dosing that could provide sustained suppression of type 2 inflammation is a promising innovation for patients in Europe with severe asthma who are in urgent need of novel solutions.”

Eugenio De Corso, md, adjunct professor of otorhinolaryngology, Catholic University of the Sacred Heart, said: “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge. An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”

Exdensur has already received approval in the US and marketing authorisation in the UK and Japan for severe asthma and CRSwNP. The depemokimab development programme continues to explore additional type 2 inflammation-driven diseases, including eosinophilic granulomatosis with polyangiitis, hyper eosinophilic syndrome, and uncontrolled moderate to severe COPD.