Drug Trials Snapshot: EBANGA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age 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 health provider about the risks and benefits of a drug. Refer to the EBANGA BRAND NAME Package Insert for complete information.

EBANGA (ansuvimab-zykl)
(ee-BAHN-guh)
Ridgeback Biotherapeutics
Approval date: December 21, 2020

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DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

EBANGA is a drug used to treat children and adults who have an infection caused by Zaire ebolavirus.

Zaire ebolavirus infection (sometimes called Ebola or Ebola virus disease) is a rare, contagious, rapidly progressive and often deadly disease.

How is this drug used?

EBANGA is an injection. It is given one time by a healthcare provider directly into the vein (intravenous infusion) over 60 minutes. The amount of the drug to be administered is based on the patient’s weight.

What are the benefits of this drug?

EBANGA lowered the risk of dying from the infection. Out of 174 patients treated with EBANGA, 61 patients (35%) died within 28-days in comparison to 83 out of the 168 patients (49%) who were treated with another experimental drug.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes the efficacy results for a pre-specified interim analysis of 28-day mortality.

Table 1. Mortality Rates in Trial 1

Efficacy Endpoints	EBANGAa N=174	Controla N=168
	Overall
28-day mortality, n (%)	61 (35%)	83 (49%)
Mortality rate difference relative to control (95% CI)b	-14.3 (-24.7, -3.7)
p-Valuec	0.008
Baseline Viral Load
High viral load (CtNP ≤ 22)d
28-day mortality, n (%)	51/73 (70%)	60/70 (86%)
Mortality rate difference relative to control (95% CI)b	-15.9 (-31.6, 0.9)
Low viral load (CtNP > 22)d
28-day mortality, n (%)	10/101 (10%)	23/97 (24%)
Mortality rate difference relative to control (95% CI)b	-13.8 (-27.3, 0.3)

N=Number of subjects in the Concurrent Intention-to-Treat population and treatment group; n=Number of subjects with the 28-day outcome. Denominator for percentages is the total number of subjects in the specific group.
^a Both EBANGA and Control were administered with optimized standard of care
^b 95% CI for Difference = 95% confidence intervals were computed by inverting two one-sided exact tests.
^c The result is significant according to the interim stopping boundary, p<0.028.
^d Cepheid GeneXpert Ebola® Assay used for detection of Zaire ebolavirus RNA
EBANGA Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: EBANGA worked similarly in males and females.
• Race: Data not collected.
• Age: EBANGA worked similarly in all tested age groups.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The table below summarizes primary efficacy results by sex and age subgroups.

Table 2. 28-Day Mortality Rates

Demographic Subgroup	EBANGA N=174	Control N=168
Sex, n/N (%)
Male	30/76 (39%)	32/81 (40%)
Female	31/98 (32%)	51/87 (59%)
Age group, n/N (%)
< 6 years of age	11/26 (42%)	8/19 (42%)
6 to < 12 years of age	4/13 (31%)	2/5 (40%)
12 to < 18 years of age	5/15 (33%)	5/9 (56%)
Adults (age ≥18 years)	41/120 (34%)	68/135 (50%)

EBANGA Prescribing Information

What are the possible side effects?

EBANGA may cause serious side effects including severe and life-threatening allergic reactions during and after the infusion.

The most common side effects of EBANGA are fever, fast heart rate, diarrhea, vomiting, low blood pressure, and chills.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse events that were reported during EBANGA infusion.

Table 3. Adverse Events That Occurred during EBANGA Infusion in ≥10% of Adult and Pediatric Patients in the Trial

Adverse Eventa	EBANGA (N=173) %	Controlb (N=168) %
Pyrexia	17	58
Tachycardia	9	32
Diarrheac	9	18
Vomitingc	8	23
Hypotension	8	31
Tachypnea	6	28
Chillsd	5	33
Hypoxiac	3	11

^aAdverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion
^bInvestigational therapy administered as three separate infusions
^cAdverse events that occurred during infusion but were not pre-specified.
^dThe term chills includes other similar adverse events including rigors and tremors

EBANGA Prescribing Information

Were there any differences in side effects among sex, race and age?

• Sex: The occurrence of side effects was similar in males and females.
• Race: Data not collected.
• Age: The occurrence of side effects was similar in all tested groups.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes the occurrence of the most frequent adverse events by sex and age subgroups. Demographic information for race was not collected.

Table 4. Subgroup Analysis of Adverse Events by Sex

Adverse Event	EBANGA N=173		Control N=168
	Male N=78 %	Female N=95 %	Male N=82 %	Female N=86 %
Any adverse event	42	40	90	87
Pyrexia	15	19	65	51
Tachycardia	8	10	27	36
Diarrhea	9	8	22	15

Clinical Trial Data

Table 5. Subgroup Analysis of Adverse Events by Age

Adverse Event	EBANGA N=173				Control N=168
	Age <6 N=12 %	Age 6-11 N=19 %	Age 12-17 N=16 %	Age ≥18 N=128 %	Age <6 N=14 %	Age 6-11 N=7 %	Age 12-17 N=11 %	Age ≥18 N=136 %
Any adverse event	42	42	44	41	79	86	100	89
Pyrexia	17	32	6	17	71	57	55	57
Tachycardia	17	21	6	6	21	29	27	33
Diarrhea	8	5	6	10	21	29	9	18

FDA Review

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved EBANGA based primarily on evidence from a clinical trial (Trial 1/ NCT NCT03719586) of 342 patients with Zaire ebolavirus infection. The trial was conducted at four sites in the Democratic Republic of Congo during an outbreak that began in August 2018.

Figure 1 summarizes how many males and females were in the clinical trial.

Figure 1. Demographics by Sex (efficacy population)

FDA Review

Demographics by Race - data not collected.

Figure 2 summarizes the percentage of patients by age.

Figure 2. Demographics by Age (efficacy population)

FDA Review

Demographics by Ethnicity - data not collected.

Who participated in the trials?

The table below summarizes demographics of patients in the trial.

Table 6. Demographic Characteristics (efficacy population)

Demographic Characteristic	EBANGA N=174	Control N=168	TOTAL N=342
Sex
Male	76 (44)	81 (48)	157 (46)
Female	98 (56)	87 (52)	185 (54)
Race (not collected)
Age (years)
Median	26	27.5	26
Min, Max	0, 85	0,70	0, 85
Age Group
0 to <1 month	4 (2)	2 (1)	6 (2)
1 month to <1 year	7 (4)	5 (3)	12 (4)
1-5 years	15 (9)	12 (7)	27 (8)
6-11 years	13 (7)	5 (3)	18 (5)
12-17 years	15 (9)	9 (5)	24 (7)
18-49 years	93 (53)	114 (68)	207 (61)
50-64 years	21 (12)	18 (11)	39 (11)
≥ 65 years	6 (3)	3 (2)	9 (3)
Ethnicity (not collected)
Geographic Region
US	0	0	0
Democratic Republic of Congo	174 (100 %)	168 (100 %)	342 (100 %)

Clinical Trial Data

How were the trials designed?

There was one trial that evaluated both, benefits and side effects of EBANGA. The trial enrolled newborn, pediatric and adult patients (including pregnant women) with Zaire ebolavirus infection. All patients received standard, supportive care for the disease. In addition to the standard care, patients were randomly assigned to receive either a one-time dose of EBANGA or one of the three other types of experimental treatments (including one as the control group). The patients and the health care providers knew which treatment was being given.

The benefit was evaluated by comparing the proportion of patients who died within 28 days from the randomization in the EBANGA-treated group to the patients in the control-treated group.

How were the trials designed?

The safety and efficacy of EBANGA were established in a multi-center, open label, randomized active-controlled trial. The trial evaluated pediatric and adult patients (including pregnant women and neonates born to a mother who had cleared Zaire ebolavirus following a course of her assigned investigational medication) who acquired Zaire ebolavirus infection. All patients received an optimized standard of care. In addition, patients were randomized to receive a single infusion of EBANGA, an investigational control intravenously every third day, totaling 3 doses, or another investigational drug.

The primary efficacy endpoint was 28-day mortality. The primary analysis population included all patients who were randomized and concurrently eligible to receive either EBANGA or the investigational control during the same time period of the trial.

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.

PRESCRIBING INFORMATION

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