Drug Trials Snapshots: NEMLUVIO
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 NEMLUVIO 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).
NEMLUVIO (nemolizumab-ilto)
(nem-LOO-vee-oh)
Galderma Laboratories, L.P.
Approval date: August 12, 2024
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
NEMLUVIO is an interleukin-31 receptor antagonist that is indicated for the treatment of adults with prurigo nodularis.
How is this drug used?
NEMLUVIO is a subcutaneous injection that is taken every four weeks.
Who participated in the clinical trials?
The FDA approved NEMLUVIO based on evidence from two clinical trials (OLYMPIA 1 and OLYMPIA 2) of 560 patients with prurigo nodularis. The trials were conducted at 132 sites in 16 countries including Austria, Belgium, Canada, Denmark, France, Netherlands, Germany, Hungary, Italy, Poland, South Korea, Spain, Sweden, Switzerland, the United Kingdom, and the United States. The trials included 99 patients inside the United States.
Among the 560 enrolled patients, all of them were evaluated for efficacy (Intent-to-Treat population) and 556 patients were evaluated for safety.
How were the trials designed?
NEMLUVIO was evaluated in two clinical trials of 560 patients with prurigo nodularis.
In both trials, patients with prurigo nodularis were randomized to receive NEMLUVIO or placebo. Patients weighing less than 90 kg in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0, followed by 30 mg injections every four weeks. Patients weighing 90 kg or more in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0 and every four weeks.
Efficacy was assessed with the proportion of subjects with an improvement of ≥4 from baseline in Peak Pruritus Numeric Rating Scale (PP-NRS), the proportion of subjects with an Investigator’s Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS <2.
How were the trials designed?
NEMLUVIO was evaluated in two clinical trials of 560 patients with prurigo nodularis. Disease severity was defined using an IGA in the overall assessment of prurigo nodularis nodules on a severity scale of 0 to 4. Subjects enrolled in these two trials had an IGA score ≥3, severe pruritus as defined by a weekly average of the PP-NRS score of ≥7 on a scale of 0 to 10, and greater than or equal to 20 nodular lesions. OLYMPIA 1 and OLYMPIA 2 assessed the effect of NEMLUVIO on the signs and symptoms of prurigo nodularis, targeting improvement in skin lesions and pruritus over 16 weeks. In OLYMPIA 1, subjects were extended up to 24 weeks of treatment.
Subjects weighing less than 90 kg in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0, followed by 30 mg injections every four weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0 and every four weeks.
The PP-NRS score is a weekly average of daily PP-NRS scores on an 11-point scale from 0 to 10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable. The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate”, or “4 = severe” indicating the investigator’s overall assessment of the pruriginous nodules.
Efficacy was assessed with the proportion of subjects with an improvement of ≥4 from baseline in PP-NRS, the proportion of subjects with an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS <2.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of NEMLUVIO.
Figure 1. Baseline Demographics by Sex, Intent-to-Treat Population
Source: Adapted from FDA Review
Figure 2 summarizes how many patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of NEMLUVIO.
Figure 2. Baseline Demographics by Race, Intent-to-Treat Population
Source: Adapted from FDA Review
Figure 3 summarizes how many patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of NEMLUVIO.
Figure 3. Baseline Demographics by Age, Intent-to-Treat Population
Source: Adapted from FDA Review
Figure 4 summarizes how many patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of NEMLUVIO.
Figure 4. Baseline Demographics by Ethnicity, Intent-to-Treat Population
Source: Adapted from FDA Review
Who participated in the trials?
Table 1. Baseline Demographics of Efficacy Trials, Intent-to-Treat1 Population
Demographic |
OLYMPIA 1 | OLYMPIA 2 | ||
|---|---|---|---|---|
| NEMLUVIO N=190 |
Placebo N=96 |
NEMLUVIO N=183 |
Placebo N=91 |
|
| Age, years | ||||
| Mean (SD) | 57.5 (12.8) | 57.6 (13.4) | 53.7 (14.4) | 50.8 (15.0) |
| Median (min, max) | 58.0 (24, 82) | 59.0 (23, 84) | 55.0 (20, 81) | 53.0 (18, 78) |
| Age group, years, n (%) | ||||
| ≤65 | 136 (72) | 68 (71) | 137 (75) | 77 (85) |
| >65 | 54 (28) | 28 (29) | 46 (25) | 14 (15) |
| Sex, n (%) | ||||
| Male | 80 (42) | 40 (42) | 70 (38) | 36 (40) |
| Female | 110 (58) | 56 (58) | 113 (62) | 55 (60) |
| Race, n (%) | ||||
| White | 160 (84) | 81 (84) | 147 (80) | 68 (75) |
| Black or African American | 18 (9) | 10 (10) | 5 (3) | 7 (8) |
| Asian | 10 (5) | 2 (2) | 23 (13) | 14 (15) |
| American Indian or Alaska Native | 1 (1) | 0 | 0 | 0 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 2 (1) | 0 |
| Other | 1 (1) | 2 (2) | 5 (3) | 2 (2) |
| Not reported | 0 | 1 (1) | 1 (1) | 0 |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 4 (2) | 5 (5) | 5 (3) | 7 (8) |
| Not Hispanic or Latino | 184 (97) | 88 (92) | 173 (95) | 79 (87) |
| Unknown or not reported | 2 (1) | 3 (3) | 5 (3) | 5 (5) |
| Country, n (%) | ||||
| United States | 44 (23) | 23 (24) | 23 (13) | 9 (10) |
| Outside United States | 146 (77) | 73 (76) | 160 (87) | 82 (90) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects.
Abbreviations: SD, standard deviation
What are the benefits of this drug?
In two trials, more patients achieved improvements in their pruritus after 16 weeks of treatment with NEMLUVIO compared to those who were treated with placebo. In addition, more patients achieved clear or almost clear skin after 16 weeks of treatment with NEMLUVIO compared to those who were treated with placebo.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 2 summarizes efficacy results in the clinical trials. Efficacy was assessed with the proportion of subjects with an improvement of ≥4 from baseline in PP-NRS, the proportion of subjects with an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS <2.
Table 2. Efficacy Results at Week 16 in Adult Subjects With PN in OLYMPIA 1 and OLYMPIA 2
Parameter |
OLYMPIA 1 | OLYMPIA 2 | ||||
|---|---|---|---|---|---|---|
| NEMLUVIO N=190 % |
Placebo N=96 % |
Difference % (95% CI) |
NEMLUVIO N=183 % |
Placebo N=91 % |
Difference % (95% CI) |
|
| Proportion of subjects with both an improvement (reduction) of ≥4 from baseline in PP-NRS and IGA 0 or 1a b | 22a | 2a | 15 (8, 21)a | 25a | 4a | 22 (14, 30)a |
| Proportion of subjects with IGA 0 or 1b | 26 | 7 | 15 (7, 23) | 38 | 11 | 29 (19, 38) |
| Proportion of subjects with an improvement (reduction) of ≥4 from baseline in PP-NRSb | 56 | 16 | 38 (27, 48) | 49 | 16 | 34 (23, 45) |
| Proportion of subjects with PP-NRS <2b | 32 | 4 | 28 (20, 36) | 31 | 7 | 26 (18, 34) |
Source: Adapted from NEMLUVIO Prescribing Information
a Not adjusted for multiplicity.
b Subjects who received rescue therapy or had missing data (fewer than 4 PP-NRS daily diary entries in a 7-day period) were considered non-responders. Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; PN, prurigo nodularis; PP-NRS, Peak Pruritus Numeric Rating Scale
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: NEMLUVIO worked similarly in males and females.
- Race: The number of patients of races other than White was limited; therefore, differences in response among races could not be determined.
- Age: NEMLUVIO worked similarly in patients younger and older than 65 years of age.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 3 to Table 8 summarizes efficacy results at Week 16 by age, sex, race, and ethnicity.
Table 3. Results for ≥4-Point Improvement on the PP-NRS From Baseline to Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 1
| Subgroup | NEMLUVIO N=190 n/Ns (%) |
Placebo N=96 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 75/136 (55) | 13/68 (19) | 36 (23, 49) |
| >65 | 31/54 (57) | 2/28 (7) | 50 (34, 67) |
| Sex | |||
| Male | 44/80 (55) | 7/40 (18) | 38 (21, 54) |
| Female | 62/110 (56) | 8/56 (14) | 42 (29, 55) |
| Race | |||
| White | 90/160 (56) | 15/81 (19) | 38 (26, 49) |
| Black or African American | 10/18 (56) | 0/10 (0) | 56 (33, 79) |
| Asian | 5/10 (50) | 0/2 (0) | 50 (19, 81) |
| Other2 | 1/2 (50) | 0/3 (0) | 50 (-19, 100) |
| Ethnicity | |||
| Hispanic or Latino | 2/4 (50) | 0/5 (0) | 50 (1, 99) |
| Not Hispanic or Latino, unknown, or not reported | 104/186 (56) | 15/91 (16) | 39 (29, 50) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported. Abbreviations: CI, confidence interval; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; PP-NRS, peak pruritus numeric rating scale
Table 4. Results for ≥4-Point Improvement on the PP-NRS From Baseline to Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 2
| Subgroup | NEMLUVIO N=183 n/Ns (%) |
Placebo N=91 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 71/137 (52) | 13/77 (17) | 35 (23, 47) |
| >65 | 18/46 (39) | 2/14 (14) | 25 (2, 48) |
| Sex | |||
| Male | 29/70 (41) | 5/36 (14) | 28 (11, 44) |
| Female | 60/113 (53) | 10/55 (18) | 35 (21, 49) |
| Race | |||
| White | 76/147 (52) | 11/68 (16) | 36 (24, 47) |
| Black or African American | 3/5 (60) | 2/7 (29) | 31 (-23, 86) |
| Asian | 7/23 (30) | 2/14 (14) | 16 (-10, 42) |
| Other2 | 3/8 (38) | 0/2 (0) | 38 (4, 71) |
| Ethnicity | |||
| Hispanic or Latino | 2/5 (40) | 1/7 (14) | 26 (-24, 76) |
| Not Hispanic or Latino, unknown, or not reported | 87/178 (49) | 14/84 (17) | 32 (21, 43) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported.
Abbreviations: CI, confidence interval; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; PP-NRS, peak pruritus numeric rating scale
Table 5. Results for IGA Score of 0 or 1 at Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 1
| Subgroup | NEMLUVIO N=190 n/Ns (%) |
Placebo N=96 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 37/136 (27) | 6/62 (9) | 18 (8, 28) |
| >65 | 13/54 (24) | 1/28 (4) | 21 (7, 34) |
| Sex | |||
| Male | 21/80 (26) | 3/40 (8) | 19 (6, 31) |
| Female | 29/110 (26) | 4/56 (7) | 19 (9, 30) |
| Race | |||
| White | 42/160 (26) | 7/81 (9) | 18 (8, 27) |
| Black or African American | 5/18 (28) | 0/10 (0) | 28 (7, 48) |
| Asian | 3/10 (30) | 0/2 (0) | 30 (2, 58) |
| Other2 | 0/2 (0) | 0/3 (0) | Not calculable |
| Ethnicity | |||
| Hispanic or Latino | 2/4 (50) | 1/5 (20) | 30 (-30, 90) |
| Not Hispanic or Latino, unknown, or not reported | 48/186 (26) | 6/91 (7) | 19 (11, 27) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported. Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
Table 6. Results for IGA Score of 0 or 1 at Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 2
| Subgroup | NEMLUVIO N=183 n/Ns (%) |
Placebo N=91 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 58/137 (42) | 10/77 (13) | 29 (18, 41) |
| >65 | 11/46 (24) | 0/14 (0) | 24 (12, 36) |
| Sex | |||
| Male | 21/70 (30) | 5/36 (14) | 16 (1, 32) |
| Female | 48/113 (42) | 5/55 (9) | 33 (22, 45) |
| Race | |||
| White | 57/147 (39) | 5/68 (7) | 31 (21, 41) |
| Black or African American | 1/5 (20) | 2/7 (29) | -9 (-57, 40) |
| Asian | 8/23 (35) | 3/14 (21) | 13 (-16, 42) |
| Other2 | 3/8 (38) | 0/2 (0) | 38 (4, 71) |
| Ethnicity | |||
| Hispanic or Latino | 4/5 (80) | 1/7 (14) | 66 (22, 100) |
| Not Hispanic or Latino, unknown, or not reported | 65/178 (37) | 9/84 (11) | 26 (16, 35) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported.
Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
Table 7. Results for Achieving Both ≥4-Point Improvement on the PP-NRS From Baseline and an IGA Score of 0 or 1 at Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 1
| Subgroup | NEMLUVIO N=190 n/Ns (%) |
Placebo N=96 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 31/136 (23) | 2/68 (3) | 20 (12, 28) |
| >65 | 10/54 (19) | 0/28 (0) | 19 (8, 29) |
| Sex | |||
| Male | 15/80 (19) | 1/40 (3) | 16 (6, 26) |
| Female | 26/110 (24) | 1/56 (2) | 22 (13, 31) |
| Race | |||
| White | 33/160 (21) | 2/81 (2) | 18 (11, 25) |
| Black or African American | 5/18 (28) | 0/10 (0) | 28 (7, 48) |
| Asian | 3/10 (30) | 0/2 (0) | 30 (2, 58) |
| Other2 | 0/2 (0) | 0/3 (0) | Not calculable |
| Ethnicity | |||
| Hispanic or Latino | 1/4 (25) | 0/5 (0) | 25 (-17, 67) |
| Not Hispanic or Latino, unknown, or not reported | 40/186 (22) | 2/91 (2) | 19 (13, 26) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported.
Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; PP-NRS, peak pruritus numeric rating scale
Table 8. Results for Achieving Both ≥4-Point Improvement on the PP-NRS From Baseline and an IGA Score of 0 or 1 at Week 16 by Subgroup, Intent-to-Treat1 Population, OLYMPIA 2
| Subgroup | NEMLUVIO N=183 n/Ns (%) |
Placebo N=91 n/Ns (%) |
Unadjusted Difference % (95% CI) |
|---|---|---|---|
| Age, years | |||
| ≤65 | 39/137 (28) | 4/77 (5) | 23 (14, 32) |
| >65 | 7/46 (15) | 0/14 (0) | 15 (5, 26) |
| Sex | |||
| Male | 12/70 (17) | 1/36 (3) | 14 (4, 25) |
| Female | 34/113 (30) | 3/55 (5) | 25 (14, 35) |
| Race | |||
| White | 40/147 (27) | 2/68 (3) | 24 (16, 33) |
| Black or African American | 1/5 (20) | 1/7 (14) | 6 (-38, 49) |
| Asian | 4/23 (17) | 1/14 (7) | 10 (-10, 31) |
| Other2 | 1/8 (13) | 0/2 (0) | 13 (-10, 35) |
| Ethnicity | |||
| Hispanic or Latino | 1/5 (20) | 0/7 (0) | 20 (-15, 55) |
| Not Hispanic or Latino, unknown, or not reported | 45/178 (25) | 4/84 (5) | 21 (13, 28) |
Source: Adapted from FDA Review
1 Intent-to-treat population: all randomized subjects. Subjects who received rescue therapy were imputed as non-responders. Missing data was imputed as non-responders.
2 Other category includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other, and not reported. Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; N, number of patients in treatment arm; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm; PP-NRS, peak pruritus numeric rating scale
What are the possible side effects?
Most common side effects include headache, atopic dermatitis, eczema, and nummular eczema.
Allergic (hypersensitivity) reactions, including facial angioedema has been reported in some patients taking NEMLUVIO.
What are the possible side effects (results of trials used to assess safety)?
Table 9. Adverse Reactions Occurring in ≥1% of Adult Subjects With Prurigo Nodularis in the NEMLUVIO Group and Greater Than Placebo in the OLYMPIA 1 and OLYMPIA 2 Trials Through Week 16, Safety Population
| Adverse Reaction | NEMLUVIO N=370 n (%) |
Placebo N=186 n (%) |
|---|---|---|
| Headache1 | 23 (6) | 6 (3) |
| Dermatitis atopic | 16 (4) | 1 (0.5) |
| Eczema | 14 (4) | 3 (2) |
| Eczema nummular | 11 (3) | 0 |
Source: NEMLUVIO Prescribing Information
1 Headache includes: headache and tension headache
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in females and males.
- Race: The occurrence of side effects was similar in Asian, Black or African American, and White patients. The number of patients of other races was limited; therefore, differences in side effects among other races could not be determined.
- Age: The occurrence of side effects was more common in patients older than 65 years of age than patients between 18 to 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
There were no substantial differences in the risk of treatment-emergent adverse events (TEAEs) in any subgroup. However, the overall safety database and individual subgroup sample sizes were not sufficient to detect clinically meaningful differences in the frequency of TEAEs between individual subgroups.
A similar proportion of male (67.6%) and female (65.8%) subjects were reported with TEAEs during the overall period in the NEMLUVIO group, compared to the corresponding male (57.9%) and female (60.9%) subjects in the placebo group, respectively. A trend towards a higher frequency of TEAEs were reported for dermatitis atopic (8.1%), eczema (6.8%), and nummular eczema (6.8%) for male subjects in the NEMLUVIO group, compared to male subjects in the placebo group and compared to female subjects.
No clinically significant differences in the frequency of TEAEs by racial or ethnic subgroups were reported during the overall period. The proportion of subjects reported with TEAEs during the overall period was higher among subjects >65 years of age in the NEMLUVIO group (74.7%) compared to subjects >65 years of age in the placebo group (56.1%) and compared to subjects between 18 to 65 years of age in the NEMLUVIO group (63.5%) or the placebo group (60.7%). The most frequently reported TEAEs in subjects >65 years of age in the NEMLUVIO group were neurodermatitis, eczema, and eczema nummular (7.1% each).
Table 10. Number of Subjects Experiencing Side Effects by Subgroup, Safety Population, Trials OLYMPIA 1 & OLYMPIA 2
| Subgroup | NEMLUVIO N=370 n/Ns (%) |
Placebo N=186 n/Ns (%) |
|---|---|---|
| Sex | ||
| Female | 146/222 (65.8) | 67/110 (60.9) |
| Male | 100/148 (67.6) | 44/76 (57.9) |
| Age group, years | ||
| 18 to 65 | 172/271 (63.5) | 88/145 (60.7) |
| >65 | 74/99 (74.7) | 23/41 (56.1) |
| Age group ≥75, years | ||
| ≥75 | 18/21 (85.7) | 7/12 (58.3) |
| Race | ||
| American Indian or Alaska Native | 1/1 (100) | 0/0 (NA) |
| Asian | 17/33 (51.5) | 7/16 (43.8) |
| Black or African American | 10/22 (45.5) | 11/17 (64.7) |
| Native Hawaiian or other Pacific Islander | 1/2 (50.0) | 0/0 (NA) |
| Other | 4/7 (57.1) | 5/5 (100) |
| White | 213/305 (69.8) | 88/148 (59.5) |
| Ethnicity | ||
| Hispanic or Latino | 5/9 (55.6) | 7/12 (58.3) |
| Not Hispanic or Latino | 236/355 (66.5) | 101/166 (60.8) |
| Not reported | 5/6 (83.3) | 3/8 (37.5) |
Source: Adapted from FDA Review
Abbreviations: N, number of patients in treatment arm; n, number of patients meeting criteria; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
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.