Drug Trials Snapshots: EXDENSUR
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the EXDENSUR Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
EXDENSUR (depemokimab)
(Ex-DEN-shur)
GLAXOSMITHKLINE, LLC
Approval date: December 16, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
EXDENSUR is a medication that is approved for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.
How is this drug used?
EXDENSUR is given once every six months by injection under the skin.
Who participated in the clinical trials?
The FDA approved EXDENSUR based on evidence from two clinical trials of 762 adult and pediatric patients with asthma. The trials were conducted at 331 sites in 23 countries including the United States, Australia, Canada, China, Czech Republic, France, Germany, Hungary, Ireland, Italy, Japan, Poland, Russia, Spain, Taiwan, and the United Kingdom. Among the 762 patients in the trials, 25% were enrolled in the United States and 75% were from outside the United States. These trials were used to assess both safety and efficacy.
How were the trials designed?
EXDENSUR was studied in two identical clinical trials with 762 patients who had asthma that was not well controlled on their background asthma medications. Patients were treated with EXDENSUR 100 mg or placebo once every six months for 52 weeks. The main goal of the trials was to see if EXDENSUR was better than placebo at reducing the rate of asthma attacks (exacerbations).
How were the trials designed?
The trials, SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103), were 52-week, randomized, double-blind, placebo-controlled studies. Patients had to have a documented physician diagnosis of asthma for at least two years with ongoing symptoms despite treatment with a medium- to high-dose inhaled corticosteroid plus ≥1 additional asthma controller with or without maintenance oral corticosteroids. All patients continued their background asthma therapy during the trials. The primary endpoint was the annualized rate of asthma exacerbations that required treatment with systemic corticosteroids and/or hospitalization and/or emergency department visit over 52 weeks.
DEMOGRAPHICS SNAPSHOT
Figure 1 shows how many male and female patients were enrolled in the clinical trials used to evaluate the efficacy of EXDENSUR.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Review
Figure 2 shows how many patients by race were enrolled in the clinical trials used to evaluate the efficacy of EXDENSUR.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Review
Figure 3 shows how many patients by age were enrolled in the clinical trials used to evaluate the efficacy of EXDENSUR.
Figure 3. Baseline Demographics by Age
Source: Adapted from FDA Review
Figure 4 shows how many patients by ethnicity were enrolled in the clinical trials used to evaluate the efficacy of EXDENSUR.
Figure 4. Baseline Demographics by Ethnicity
Source: Adapted from FDA Review
Who participated in the trials?
Table 1. Baseline Demographics of Efficacy Trials
| Demographic | SWIFT-1 | SWIFT-2 | ||||
|---|---|---|---|---|---|---|
| EXDENSUR N=250 |
Placebo N=132 |
Overall N=382 |
EXDENSUR N=252 |
Placebo N=128 |
Overall N=380 |
|
| Sex, n (%) | ||||||
| Female | 144 (58) | 79 (60) | 223 (58) | 160 (63) | 81 (63) | 241 (63) |
| Male | 106 (42) | 53 (40) | 159 (42) | 92 (37) | 47 (37) | 139 (37) |
| Age, years | ||||||
| Mean (SD) | 54 (14) | 54 (15) | 54 (14) | 54 (16) | 51 (17) | 53 (16) |
| Median (min, max) | 56 (14, 79) | 56 (15, 78) | 56 (14, 79) | 57 (12, 82) | 53 (12, 81) | 56 (12, 82) |
| Age group, years, n (%) | ||||||
| 12 to 17 | 3 (1) | 5 (4) | 8 (2) | 12 (5) | 10 (8) | 22 (6) |
| 18 to 64 | 185 (74) | 91 (69) | 276 (72) | 169 (67) | 93 (73) | 262 (69) |
| ≥65 | 62 (25) | 36 (27) | 98 (26) | 71 (28) | 25 (20) | 96 (25) |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 12 (5) | 11 (8) | 23 (6) | 45 (18) | 20 (16) | 65 (17) |
| Not Hispanic or Latino | 238 (95) | 121 (92) | 359 (94) | 207 (82) | 108 (84) | 315 (83) |
| Race, n (%) | ||||||
| Asian | 38 (15) | 20 (15) | 58 (15) | 52 (21) | 23 (18) | 75 (20) |
| Black or African American | 5 (2) | 3 (2) | 8 (2) | 17 (7) | 11 (9) | 28 (7) |
| White | 207 (83) | 109 (83) | 316 (83) | 181 (72) | 91 (73) | 272 (73) |
| Unknown | 0 (0) | 0 (0) | 0 (0) | 2 (1) | 3 (2) | 5 (1) |
| Geographical region, n (%) | ||||||
| Europe | 158 (63) | 85 (64) | 243 (64) | 108 (43) | 57 (45) | 165 (43) |
| United States | 33 (13) | 18 (14) | 51 (13) | 90 (36) | 46 (36) | 136 (36) |
| Rest of the world | 59 (24) | 29 (22) | 88 (23) | 54 (21) | 25 (20) | 79 (21) |
| BMI (kg/m²) | ||||||
| Mean (SD) | 28 (6) | 29 (7) | 28 (6) | 29 (6) | 29 (7) | 29 (6) |
| Median (min, max) | 27 (15, 53) | 27 (19, 53) | 27 (15, 53) | 28 (14, 49) | 28 (16, 57) | 28 (14, 57) |
Source: Adapted from FDA Review
Abbreviations: BMI, body mass index; SD, standard deviation
What are the benefits of this drug?
EXDENSUR helped reduce the rate of asthma attacks (exacerbations) in adults and pediatric patients aged 12 years and older over a one-year period.
What are the benefits of this drug (results of trials used to assess efficacy)?
The SWIFT-1 and SWIFT-2 trials demonstrated that treatment with EXDENSUR was superior to placebo in patients aged 12 years and older with asthma. In both trials, EXDENSUR showed a reduction in the rate of asthma exacerbations over 52 weeks compared to placebo.
Table 2. Annualized Rate of Clinically Significant Asthma Exacerbations Over 52 Weeks, Efficacy Population
| Parameter | SWIFT-1 | SWIFT-2 | ||
|---|---|---|---|---|
| EXDENSUR N=250* |
Placebo N=132 |
EXDENSUR N=252 |
Placebo N=128 |
|
| Annualized asthma exacerbation rate (95% CI) | 0.46 (0.35, 0.58) | 1.1 (0.81, 1.38) | 0.54 (0.41, 0.67) | 1.05 (0.76, 1.33) |
| Rate ratioa (95% CI) | 0.42 (0.3, 0.6) | 0.52 (0.36, 0.73) | ||
| Percent reductionb (95% CI) | 58 (40, 70) | 48 (27, 64) | ||
Source: Adapted from FDA Review
* One SWIFT-1 participant in the EXDENSUR group was removed from analysis due to missing covariate data
a Calculated as the annualized rate in the EXDENSUR arm divided by the annualized rate in the placebo arm
b Calculated as: (1 – rate ratio) * 100%
Abbreviations: CI, confidence interval
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: EXDENSUR worked similarly in males and females.
- Race: The number of patients of races other than White was small; therefore, differences in how EXDENSUR worked among other races could not be determined.
- Age: EXDENSUR worked similarly in patients 18 to 64 years of age and ≥65 years of age. The number of patients 12 to 17 years of age was small; therefore, differences in how EXDENSUR worked among other ages could not be determined.
- Ethnicity: EXDENSUR worked similarly in Hispanic or Latino and not Hispanic or Latino patients.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Subgroup analyses of the primary endpoint based on sex, race, age, and ethnicity were performed. In general, there were no significant differences in the efficacy of EXDENSUR based on the demographic subgroups, but some subgroups were small; therefore, differences in certain subgroups could not be determined.
Table 3. Efficacy Results by Subgroup, Efficacy Population
| Subgroup | SWIFT-1 | SWIFT-2 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EXDENSUR | Placebo | Rate Ratio (95% CI) | EXDENSUR | Placebo | Rate Ratio (95% CI) | |||||||
| N* | Annual Rate | N | Annual Rate | N | Annual Rate | N | Annual Rate | |||||
| Sex | ||||||||||||
| Female | 143 | 0.44 | 79 | 1.12 | 0.4 (0.26, 0.61) | 160 | 0.60 | 81 | 1.15 | 0.52 (0.33, 0.82) | ||
| Male | 106 | 0.47 | 53 | 1.02 | 0.46 (0.26, 0.79) | 92 | 0.39 | 47 | 0.93 | 0.42 (0.24, 0.72) | ||
| Race | ||||||||||||
| Asian | 38 | 0.32 | 20 | 2.18 | 0.15 (0.07, 0.3) | 52 | X | 23 | X | X (X, X) | ||
| Black or African American | 5 | X | 3 | X | X (X, X) | 17 | 0.79 | 11 | 0.65 | 1.22 (0.2, 6.84) | ||
| White | 206 | 0.50 | 109 | 0.96 | 0.51 (0.35, 0.75) | 181 | 0.49 | 91 | 0.93 | 0.45 (0.3, 0.66) | ||
| Age group, years | ||||||||||||
| 12 to 17 | 3 | X | 5 | X | X (X, X) | 12 | 0.40 | 10 | 0.57 | 0.7 (0.19, 2.43) | ||
| 18 to 64 | 184 | 0.47 | 91 | 1.08 | 0.43 (0.28, 0.66) | 169 | 0.63 | 93 | 1.11 | 0.57 (0.38, 0.84) | ||
| ≥65 | 62 | 0.44 | 36 | 1.24 | 0.36 (0.2, 0.64) | 71 | 0.41 | 25 | 1.13 | 0.36 (0.14, 0.87) | ||
| Ethnicity | ||||||||||||
| Hispanic or Latino | 11 | 0.09 | 11 | 1.49 | 0.06 (0, 0.61) | 45 | 0.03 | 20 | 0.16 | 0.2 (0.01, 1.51) | ||
| Not Hispanic or Latino | 238 | 0.48 | 121 | 1.06 | 0.45 (0.32, 0.63) | 207 | 0.67 | 108 | 1.22 | 0.55 (0.39, 0.77) | ||
Source: Adapted from FDA review
* One SWIFT-1 participant in the EXDENSUR group was removed from analysis due to missing covariate data
Abbreviations: CI, confidence interval; X, value not available due to limited data
What are the possible side effects?
The most common side effects of EXDENSUR include upper respiratory tract infection (common cold), allergic rhinitis (sneezing, runny nose), influenza (flu or flu-like symptoms), arthralgia (joint pain), and pharyngitis (sore throat). EXDENSUR may also cause hypersensitivity reactions (allergic reactions), symptoms at the injection site such as redness and itching, and increase a person’s risk of getting infections from parasites. For those who are pregnant, it is important to know that EXDENSUR is a long-acting medicine that stays in the body for a while with the potential to pass from the mother to an unborn baby. Therefore, the possible effects on the baby should be considered.
What are the possible side effects (results of trials used to assess safety)?
The safety profile was evaluated in 762 patients during the 52-week placebo-controlled period. The most common adverse reactions (≥4% and greater than placebo) are shown in Table 4.
Table 4. Safety Results, Safety Population
| Adverse Reaction | EXDENSUR N=501 n (%) |
Placebo N=261 n (%) |
|---|---|---|
| Upper respiratory tract infection | 46 (9) | 20 (8) |
| Allergic rhinitis | 29 (6) | 7 (3) |
| Influenza | 24 (5) | 11 (4) |
| Arthralgia | 19 (4) | 8 (3) |
| Pharyngitis | 18 (4) | 3 (1) |
Source: Adapted from FDA Review
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was more common in females than males treated with EXDENSUR.
- Race: The occurrence of side effects was more common in Asian than White patients treated with EXDENSUR. The number of patients of other races was small; therefore, differences in side effects among other races could not be determined. Upper respiratory tract infection and allergic rhinitis was more common in Asian than White patients treated with EXDENSUR.
- Age: The occurrence of side effects was similar in patients 18 to 64 and ≥65 years of age treated with EXDENSUR, though upper respiratory tract infection and pharyngitis was more common in patients 18 to 64 than those ≥65 years of age treated with EXDENSUR. The number of patients in other age groups was small; therefore, differences in side effects could not be determined.
- Ethnicity: The occurrence of side effects was more common in not Hispanic or Latino patients than Hispanic or Latino patients treated with EXDENSUR. The occurrence of upper respiratory tract infection and allergic rhinitis was more common in not Hispanic or Latino patients than Hispanic or Latino patients treated with EXDENSUR.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
There were some differences in the safety profile based on sex, race, age, and ethnicity; however, none are likely to be clinically meaningful or warrant a limitation of use in certain populations.
Table 5. Side Effects by Subgroup, Safety Population
| Subgroup | Treatment Arm | Any AE n/Ns (%) |
URTI n/Ns (%) |
Allergic Rhinitis n/Ns (%) |
Pharyngitis n/Ns (%) |
|---|---|---|---|---|---|
| Sex | |||||
| Female | EXDENSUR | 228/303 (75) | 28/303 (9) | 16/303 (5) | 10/303 (3) |
| Placebo | 124/161 (77) | 12/161 (8) | 3/161 (2) | 2/161 (1) | |
| Male | EXDENSUR | 134/198 (68) | 18/198 (9) | 13/198 (7) | 8/198 (4) |
| Placebo | 74/100 (74) | 8/100 (8) | 4/100 (4) | 1/100 (1) | |
| Race | |||||
| American Indian or Alaska Native | EXDENSUR | 1/2 (50) | 0/2 (0) | 0/2 (0) | 0/2 (0) |
| Placebo | 1/1 (100) | 0/1 (0) | 0/1 (0) | 0/1 (0) | |
| Asian | EXDENSUR | 84/90 (93) | 19/90 (21) | 9/90 (10) | 2/90 (2) |
| Placebo | 38/43 (88) | 10/43 (23) | 2/43 (5) | 0/43 (0) | |
| Black or African American | EXDENSUR | 12/22 (55) | 3/22 (14) | 0/22 (0) | 0/22 (0) |
| Placebo | 10/14 (71) | 0/14 (0) | 1/14 (7) | 0/14 (0) | |
| White | EXDENSUR | 265/387 (69) | 24/387 (6) | 0/387 (5) | 16/387 (4) |
| Placebo | 148/201 (74) | 10/201 (5) | 4/201 (2) | 3/201 (2) | |
| Age group, years | |||||
| 12 to 17 | EXDENSUR | 11/15 (73) | 2/15 (13) | 0/15 (0) | 3/15 (20.0) |
| Placebo | 9/15 (60) | 1/15 (7) | 1/15 (7) | 0/15 (0) | |
| 18 to 64 | EXDENSUR | 254/353 (72) | 35/353 (10) | 20/353 (6) | 14/353 (4) |
| Placebo | 145/185 (78) | 17/185 (9) | 5/185 (3) | 3/185 (2) | |
| ≥65 | EXDENSUR | 97/133 (73) | 9/133 (7) | 9/133 (7) | 1/133 (1) |
| Placebo | 44/61 (72) | 2/61 (3) | 1/61 (2) | 0/61 (0) | |
| Ethnicity | |||||
| Hispanic or Latino | EXDENSUR | 28/57 (49) | 3/57 (5) | 1/57 (2) | 1/57 (2) |
| Placebo | 19/31 (61) | 0/31 (0) | 0/31 (0) | 0/31 (0) | |
| Not Hispanic or Latino | EXDENSUR | 334/444 (75) | 43/444 (10) | 28/444 (6) | 17/444 (4) |
| Placebo | 179/230 (78) | 20/230 (9) | 7/230 (3) | 3/230 (1) | |
Source: Adapted from FDA Review
Abbreviations: AE, adverse event; N, number of patients in treatment arm; n, number of patients with adverse event; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; URTI, upper respiratory tract infection
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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