Atoltivimab/maftivimab/odesivimab

Atoltivimab/maftivimab/odesivimab, sold under the brand name Inmazeb, is a fixed-dose combination of three monoclonal antibodies for the treatment of Zaire ebolavirus (Ebola virus).[2] It contains atoltivimab, maftivimab, and odesivimab-ebgn.[2]

Atoltivimab/maftivimab/odesivimab
Combination of
AtoltivimabMonoclonal antibody
MaftivimabMonoclonal antibody
OdesivimabMonoclonal antibody
Clinical data
Trade namesInmazeb
Other namesREGN-EB3
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

The most common side effects include fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting; however, these are also common symptoms of Ebola virus infection.[2][3]

Atoltivimab/maftivimab/odesivimab is a combination of Zaire ebolavirus glycoprotein-directed human monoclonal antibodies.[2] Atoltivimab/maftivimab/odesivimab targets the glycoprotein that is on the surface of Ebola virus.[2] Glycoprotein attaches to the cell receptor and fuses the viral and host cell membranes allowing the virus to enter the cell.[2] The three antibodies can bind to this glycoprotein simultaneously and block attachment and entry of the virus.[2]

The U.S. Food and Drug Administration (FDA) approved Ervebo, the first vaccine for the prevention of Ebola virus disease, in December 2019.[2] Atoltivimab/maftivimab/odesivimab is the first FDA-approved treatment for Zaire ebolavirus.[2] Atoltivimab/maftivimab/odesivimab was approved for medical use in the United States in October 2020.[2][4][5][3][6] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

Medical uses

Atoltivimab/maftivimab/odesivimab is indicated for the treatment of infection caused by Zaire ebolavirus.[2]

Contraindications

People who receive atoltivimab/maftivimab/odesivimab should avoid the concurrent administration of a live vaccine due to the treatment's potential to inhibit replication of a live vaccine virus indicated for prevention of Ebola virus infection and possibly reduce the vaccine's efficacy.[2]

History

Atoltivimab/maftivimab/odesivimab was evaluated in 382 adult and pediatric participants with confirmed Zaire ebolavirus infection in one clinical trial (the PALM trial) and as part of an expanded access program conducted in the Democratic Republic of the Congo (DRC) during an Ebola virus outbreak in 2018-2019.[2][3] In the PALM trial, the safety and efficacy of atoltivimab/maftivimab/odesivimab was evaluated in a multi-center, open-label, randomized controlled trial, in which 154 participants received atoltivimab/maftivimab/odesivimab (50 mg of each monoclonal antibody) intravenously as a single infusion, and 168 participants received an investigational control.[2] The trial enrolled pediatric and adult participants (including pregnant women) with Zaire ebolavirus infection.[3] All participants received standard, supportive care for the disease.[3] The participants and the health care providers knew which treatment was being given.[3] The primary efficacy endpoint was 28-day mortality.[2] The primary analysis population was all participants who were randomized and concurrently eligible to receive either atoltivimab/maftivimab/odesivimab or the investigational control during the same time period of the trial.[2] Of the 154 participants who received atoltivimab/maftivimab/odesivimab, 33.8% died after 28 days, compared to 51% of the 153 participants who received a control.[2] In the expanded access program, an additional 228 participants received atoltivimab/maftivimab/odesivimab.[2]

The FDA granted the application of atoltivimab/maftivimab/odesivimab-ebgn orphan drug and breakthrough therapy designations.[2] The FDA granted the approval of Inmazeb to Regeneron Pharmaceuticals.[2][6]

References
  1. "Inmazeb- atoltivimab, maftivimab, and odesivimab-ebgn injection, solution". DailyMed. Retrieved 17 January 2021.
  2. "FDA Approves First Treatment for Ebola Virus". U.S. Food and Drug Administration (FDA) (Press release). 14 October 2020. Retrieved 14 October 2020. This article incorporates text from this source, which is in the public domain.
  3. "Drug Trials Snapshots: Inmazeb". U.S. Food and Drug Administration. 14 October 2020. Retrieved 23 October 2020. This article incorporates text from this source, which is in the public domain.
  4. "Regeneron's Antibody Cocktail REGN-EB3 (Inmazeb) is First FDA-Approved Treatment for Ebola (Zaire Ebolavirus)". Regeneron Pharmaceuticals Inc. (Press release). 14 October 2020. Retrieved 14 October 2020.
  5. "Inmazeb: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 15 October 2020.
  6. "Drug Approval Package: Inmazeb". U.S. Food and Drug Administration. 12 November 2020. Retrieved 23 December 2020.
  7. "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.

Further reading
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