The US FDA has approved depemokimab as an add-on maintenance therapy for individuals aged 12 years or older with severe asthma, according to a press release from manufacturer GlaxoSmithKline.

Depemokimab-ulaa, marketed as Exdensur, is the first long-acting biologic to be studied for respiratory diseases with underlying type 2 inflammation, and the product’s distinctive half-life allows for twice-yearly doses of 100 mg subcutaneously, according to the company. 

The approval was based on data from a pair of phase III studies, SWIFT-1 and SWIFT-2, which showed sustained reductions in asthma exacerbations with two doses per year as an add-on to standard of care compared to placebo plus standard of care.

Asthma exacerbations decreased by 58% and 48% in the SWIFT-1 and SWIFT-2 studies, respectively, from baseline to 52 weeks (P < .001 in both studies). Additionally, the annualized exacerbation rates were significantly lower in patients who received depemokimab vs placebo across both studies (0.46 vs 1.11 and 0.56 vs 1.08, respectively; P < .001 for both). 

Secondary endpoint analysis also showed significantly fewer exacerbations requiring emergency department visits and/or hospitalizations.

Adverse events were similar in both treatment and placebo groups across both studies; the most common included upper respiratory infections such as colds and sinus infections, headache, itching, injection-site reactions, and flu-like symptoms.

The drug is indicated for patients with a particular eosinophilic phenotype of asthma that is often resistant to other treatments, according to the company. The study population included individuals aged 12 years or older with an eosinophil count of at least 300 cells/µL in the previous 12 months or at least 150 cells/µL at screening, with a history of exacerbations despite use of medium- or high-dose inhaled glucocorticoids.

Depemokimab also has received marketing authorization in the UK from the Medicines and Healthcare products Regulatory Agency and a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use; submissions are under review in other countries as well, including China and Japan, according to the company.

Full prescribing information is available here.

The studies were supported by GlaxoSmithKline.