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Drug Trials Snapshots: INMAZEB

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.

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 INMAZEB Package Insert for complete information.

INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn)
Approval date: October 14, 2020


What is the drug for?

INMAZEB is a drug used to treat pediatric and adult patients 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?

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

What are the benefits of this drug?

INMAZEB lowered the risk of dying from the infection. Out of 154 patients treated with INMAZEB, 52 patients (34%) died within 28-days in comparison to 78 out the 153 patients (51%) who were treated with another experimental drug.

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

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

What are the possible side effects?

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

The most common side effects of INMAZEB are fever, chills, fast heart rate, fast breathing and vomiting.

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.


Who participated in the trials?

The FDA approved INMAZEB based primarily on evidence from a clinical trial (Trial 1/ NCT NCT03719586) of 322 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 (safety population)

Pie chart summarizing how many males and females were in the clinical trials. In total, 145 males (45%) and 177 females (55%) participated in the clinical trial.

Clinical Trial Data

Baseline Demographics by Race - data not collected.

Figure 2 summarizes the percentage of patients by age.

Figure 2. Demographics by Age (safety population)

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 43 patients were less than 6 years old (13%), 12 patients were between 6-11 years old (4%), 16 patients were between 12-17 years old (5%), and 251 patients were 18 years and older (78%).

Clinical Trial Data

Demographics by Ethnicity - data not collected.

How were the trials designed?

There was one trial that evaluated both, benefits and side effects of INMAZEB. The trial enrolled 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 INMAZEB 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 their trial enrollment in the INMAZEB-treated group to the patients who received the control treatment.


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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