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          Drug Trials Snapshot: EBANGADrug Approvals and Databases Drug Trials Snapshot: EBANGA
  
  	
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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

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.

MORE INFO
	**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=168Overall28-day mortality, n (%)
			61 (35%)
			83 (49%)Mortality rate difference relative to control (95% CI)b
			-14.3 (-24.7, -3.7)p-Valuec
			0.008Baseline Viral LoadHigh viral load (CtNP ≤ 22)d28-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)d28-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 careb 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.MORE INFO
	**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=168Sex, 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.

MORE INFO
	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
			58Tachycardia
			9
			32Diarrheac
			9
			18Vomitingc
			8
			23Hypotension
			8
			31Tachypnea
			6
			28Chillsd
			5
			33Hypoxiac
			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 infusionbInvestigational therapy administered as three separate infusionscAdverse 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.MORE INFO
	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=168Male
			N=78
			%
			Female
			N=95
			%
			Male
			N=82
			%
			Female
			N=86
			%Any adverse event
			42
			40
			90
			87Pyrexia
			15
			19
			65
			51Tachycardia
			8
			10
			27
			36Diarrhea
			9
			8
			22
			15

Clinical Trial Data

**Table 5. Subgroup Analysis of Adverse Events by Age**

Adverse Event
			EBANGA
			N=173
			Control
			N=168Age <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
			89Pyrexia
			17
			32
			6
			17
			71
			57
			55
			57Tachycardia
			17
			21
			6
			6
			21
			29
			27
			33Diarrhea
			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)**

Pie chart summarizing how many men and women were in the clinical trials.
FDA Review

**Demographics by Race - data not collected.**

Figure 2 summarizes the percentage of patients by age.

**Figure 2. Demographics by Age (efficacy population)**

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 45 patients were less than 6 years old (13%), 18 patients were between 6-11 years old (5%), 24 patients were between 12-17 years old (7%), 246 patients were between 18-64 years old (72%), and 9 patients were 65 years and older (3%).
FDA Review

**Demographics by Ethnicity - data not collected.**

MORE INFO
	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=342SexMale
			76 (44)
			81 (48)
			157 (46)Female
			98 (56)
			87 (52)
			185 (54)Race (not collected)Age (years)Median
			26
			27.5
			26Min, Max
			0, 85
			0,70
			0, 85Age Group0 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 RegionUS
			0
			0
			0Democratic 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.

MORE INFO
	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

Back to Drug Trials Snapshots

                                                                                  Content current as of:
      01/13/2021Drug Approvals and Databases

          
                        


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