Drug Update · Pulmonology

FDA Approves depemokimab for Severe Eosinophilic Asthma: Rate Ratio 0.42

July 10, 2026

Approval date

December 16, 2025

Approved indication

Add‑on maintenance treatment of severe asthma with an eosinophilic phenotype in patients aged ≥12 years

FDA‑approved dose

100 mg subcutaneously once every 6 months

SWIFT‑1 annualized exacerbation rate

0.46 with depemokimab vs 1.11 with placebo (rate ratio 0.42; 95% CI, 0.30 to 0.59)

SWIFT‑2 annualized exacerbation rate

0.56 with depemokimab vs 1.08 with placebo (rate ratio 0.52; 95% CI, 0.36 to 0.73)

Patients randomized (both trials)

792 randomized; 762 included in full analysis

Clinical Perspective

Pulmonologists and clinicians who manage severe asthma now have an FDA‑approved IL‑5 antagonist option for add‑on maintenance treatment in patients aged 12 years and older with an eosinophilic phenotype. The regulatory decision was supported by SWIFT‑1 and SWIFT‑2, which demonstrated lower annualized exacerbation rates with depemokimab versus placebo (rate ratios 0.42 and 0.52) ^[1]^[3]. How depemokimab will compare directly with other biologic or anti‑IL‑5 therapies in routine practice and which patients derive the greatest long‑term benefit remain open clinical questions?

Dr. Nikhil Chatterjee · Pulmonology

The FDA approved depemokimab (EXDENSUR) on December 16, 2025 for add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in patients aged 12 years and older based on the replicate phase 3 trials SWIFT‑1 and SWIFT‑2, which showed lower annualized rates of clinically significant exacerbations versus placebo (rate ratio, 0.42 in SWIFT‑1) ^[2]^[3]^[1]. The FDA‑approved regimen is 100 mg administered subcutaneously once every 6 months (consult current prescribing information for full dosing guidance) ^[3].

Clinical Context

Depemokimab (brand EXDENSUR) is an interleukin‑5 (IL‑5) antagonist (humanized IgG1 kappa monoclonal antibody) developed by GlaxoSmithKline for severe eosinophilic asthma. Depemokimab binds IL‑5 and inhibits IL‑5 signaling, reducing eosinophil production and survival; it contains an Fc YTE substitution that extends half‑life to support 6‑month dosing intervals ^[3]. The FDA approval covers add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adults and pediatric patients aged 12 years and older ^[2]^[3]. The regulatory decision was informed by two replicate 52‑week randomized, placebo‑controlled trials (SWIFT‑1 and SWIFT‑2) demonstrating reductions in the annualized rate of clinically significant exacerbations ^[1]^[3].

Key Findings

The SWIFT‑1 trial showed depemokimab reduced the annualized rate of clinically significant exacerbations to 0.46 versus 1.11 with placebo (rate ratio, 0.42; 95% CI, 0.30 to 0.59; P<0.001) in patients with severe asthma with an eosinophilic phenotype ^[1].
The SWIFT‑2 trial showed depemokimab reduced the annualized rate of clinically significant exacerbations to 0.56 versus 1.08 with placebo (rate ratio, 0.52; 95% CI, 0.36 to 0.73; P<0.001) in a similar population ^[1].
Across the two replicate trials, 792 (exact figure not confirmed in public source summary) patients were randomized and 762 were included in the full analysis; 502 (exact figure not confirmed in public source summary) patients received depemokimab and 260 received placebo in the pooled analysis reported in the NEJM primary publication ^[1].
The proportion of patients experiencing any exacerbation during 52 weeks was lower in the depemokimab groups (32% in each trial) compared with placebo (46% and 50% in SWIFT‑1 and SWIFT‑2, respectively) ^[3]^[1].
The FDA summarized the approval noting the trials enrolled adults and pediatric patients aged 12 years and older and that EXDENSUR is given once every 6 months by subcutaneous injection as add‑on maintenance therapy ^[2]^[3].

Safety & Tolerability

The proportion of patients with any adverse event was similar in the depemokimab and placebo groups in both trials ^[1].

Study Design

The FDA approval was based on two replicate phase 3, randomized, double‑blind, placebo‑controlled trials (SWIFT‑1 and SWIFT‑2) of 52 weeks duration in patients aged 12 years and older with severe asthma and an eosinophilic phenotype ^[1]^[3]. In the trials, patients were randomized 2:1 to depemokimab 100 mg subcutaneously (administered once every 6 months) (consult current prescribing information for full dosing guidance) or placebo, in addition to standard background asthma therapy, with the primary endpoint the annualized rate of clinically significant exacerbations over 52 weeks ^[1]^[3]. Across both trials, 792 (exact figure not confirmed in public source summary) patients were randomized and 762 were included in the full analysis; 502 (exact figure not confirmed in public source summary) received depemokimab and 260 received placebo ^[1].

FAQ

Q1 What is depemokimab (EXDENSUR) approved for?

EXDENSUR (depemokimab) is approved as add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. This FDA approval was issued on December 16, 2025 and covers patients with documented eosinophilic phenotype criteria enrolled in the pivotal SWIFT‑1 and SWIFT‑2 trials.

Q2 How does depemokimab work?

Depemokimab is a humanized IgG1 kappa monoclonal antibody that binds interleukin‑5 (IL‑5) and inhibits IL‑5 signaling, thereby reducing production and survival of eosinophils. The molecule includes an Fc YTE substitution that increases neonatal Fc receptor binding and prolongs elimination half‑life, supporting dosing once every 6 months.

Q3 What is the recommended dose of depemokimab (EXDENSUR)?

The FDA‑approved dose is 100 mg administered subcutaneously once every 6 months (consult current prescribing information for full dosing guidance); EXDENSUR should be administered by a healthcare provider. The approval and dosing are based on the SWIFT‑1 and SWIFT‑2 trials in which depemokimab demonstrated reductions in annualized exacerbation rates compared with placebo.

Q4 What are the most common side effects of depemokimab?

Information was not available in the provided source excerpts.

FDA Approves depemokimab for Severe Eosinophilic Asthma: Rate Ratio 0.42

FDA Approves depemokimab for Severe Eosinophilic Asthma: Rate Ratio 0.42

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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