FDA approves Exdensur (depemokimab) to treat severe asthma with eosinophilic phenotype

On December 16, 2025, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has officially approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for patients 12 years of age and older with severe asthma characterized by an eosinophilic phenotype. The approval covers adult and adolescent patients and provides a new long-acting biologic option for long-term control of asthma exacerbations.

1. Approval Background: Urgent need for long-term control of severe asthma

Patients with severe asthma may frequently experience asthma exacerbations even when using moderate to high doses of inhaled corticosteroids in combination with other controller drugs. Among these patients, more than 80% have type 2 inflammation characterized by elevated eosinophils, which is an important driver of disease recurrence and progression. In recent years, biological agents have significantly improved the prognosis of some patients, but frequent injections and insufficient compliance are still practical problems that limit their widespread application.

2. Key clinical evidence:SWIFT-1 and SWIFT-2 phase III studies

The FDA's approval of Exdensur was mainly based on two global phase III clinical trials, SWIFT-1 and SWIFT-2. In both studies, all patients received twice-yearly doses of depemokimab or placebo in addition to standard care. The study results showed that depemokimab significantly reduced annual asthma exacerbation rates over 52 weeks compared with placebo:

1. In theSWIFT-1 study, the asthma exacerbation rate was reduced by approximately 58%;

2. In theSWIFT-2 study, the asthma exacerbation rate dropped by approximately 48%.

These results demonstrate that Exdensur provides sustained and stable disease control even when administered only twice a year.

3. Reduce hospitalizations and emergency department visits and ease the medical burden

In the secondary endpoints of the two studies, depemokimab also showed significant advantages. Compared with the placebo group, patients treated with Exdensur had significantly fewer exacerbations requiring hospitalization or emergency room treatment.

A pooled analysis ofSWIFT-1 and SWIFT-2 showed that the annualized rate of clinically significant deterioration requiring hospitalization and/or emergency department visits decreased by more than 70% over 52 weeks, suggesting that this drug not only reduces the number of exacerbations but may also significantly reduce the use of medical resources.

4. Safety and tolerability: equivalent to placebo

In theSWIFT series, depemokimab was generally well tolerated. The incidence and severity of adverse reactions in patients in the treatment group were similar to those in the placebo group, and no new safety signals were observed. This result is particularly important for patients with severe asthma who require long-term maintenance treatment.

5.Exdensur’s innovative advantages: long-acting mechanism of twice-a-year dosing

Exdensur is a new generation of ultra-long-acting biologics that achieves sustained inhibition of type 2 inflammatory pathways by extending its half-life and requires only two injections per year. This dosing model is expected to significantly improve patient compliance, reduce missed doses and discontinuations, while reducing the overall burden on patients, doctors and the medical system. This innovation has important practical significance for patients who have previously had difficulty adhering to biological treatments due to frequent injections.

6. Clinical positioning and usage precautions

Exdensur is suitable for use as long-term add-on maintenance therapy in patients with severe asthma aged 12 years and above who have eosinophil-related manifestations. This medicine is not intended to relieve acute bronchospasm or asthma exacerbations and should still be used in conjunction with regular first aid and controller medications.

Reference materials: UpdatedDecember 16, 2025, https://www.drugs.com/newdrugs/fda-approves-exdensur-depemokimab-ulaa-severe-asthma-eosinophilic-phenotype-6696.html