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((Short description|Fixed-dose combination of three monoclonal antibodies))
((Use American English|date=October 2020))
((Use dmy dates|date=October 2020))
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((Infobox drug
| drug_name          = 
| type               = combo
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<!-- Combo data -->
| component1         = Atoltivimab
| class1             = [[Monoclonal antibody]]
| component2         = Maftivimab
| class2             = Monoclonal antibody
| component3         = Odesivimab
| class3             = Monoclonal antibody

<!-- Clinical data -->
| tradename          = Inmazeb
| Drugs.com          = ((drugs.com|monograph|atoltivimab-maftivimab-and-odesivimab-ebgn))
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| legal_US           = Rx-only
| legal_US_comment   = <ref name="Inmazeb FDA label">((cite web | title=Inmazeb- atoltivimab, maftivimab, and odesivimab-ebgn injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | access-date=17 January 2021))</ref><ref name="FDA PR" />
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| UNII               = 
| KEGG               = D11922
| ChEBI              = 
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| synonyms           = REGN-EB3

<!-- Chemical and physical data -->
))

'''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).<ref name="FDA PR" /> It contains [[atoltivimab]], [[maftivimab]], and [[odesivimab|odesivimab-ebgn]] and was developed by [[Regeneron Pharmaceuticals]].<ref name="FDA PR" />

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.<ref name="FDA PR" /><ref name="FDA snapshot" />

Atoltivimab/maftivimab/odesivimab is the first FDA-approved treatment for ''Zaire ebolavirus''.<ref name="FDA PR" /> Atoltivimab/maftivimab/odesivimab was approved for medical use in the United States in October 2020.<ref name="FDA PR" /><ref>((cite press release | title=Regeneron's Antibody Cocktail REGN-EB3 (Inmazeb) is First FDA-Approved Treatment for Ebola (Zaire Ebolavirus) | website=Regeneron Pharmaceuticals Inc. | date=14 October 2020 | url=https://newsroom.regeneron.com/news-releases/news-release-details/regenerons-antibody-cocktail-regn-eb3-inmazebr-first-fda | access-date=14 October 2020))</ref><ref>((cite web | title=Inmazeb: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761169 | access-date=15 October 2020))</ref><ref name="FDA snapshot">((cite web | title=Drug Trials Snapshots: Inmazeb | website=U.S. [[Food and Drug Administration]] | date=14 October 2020 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inmazeb | access-date=23 October 2020)) ((PD-notice))</ref><ref name="Drug Approval Package">((cite web | title=Drug Approval Package: Inmazeb | website=U.S. [[Food and Drug Administration]] | date=12 November 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761169Orig1s000TOC.cfm | access-date=23 December 2020))</ref> The U.S. [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref>((cite web | title=New Drug Therapy Approvals 2020 | website=U.S. [[Food and Drug Administration]] (FDA) | date=31 December 2020 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020 | access-date=17 January 2021))</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO23rd">((cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free ))</ref>

== Medical uses ==
Atoltivimab/maftivimab/odesivimab is [[Indication (medicine)|indicated]] for the treatment of infection caused by ''Zaire ebolavirus''.<ref name="FDA PR">((cite press release | title=FDA Approves First Treatment for Ebola Virus | website=U.S. [[Food and Drug Administration]] (FDA) | date=14 October 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus | access-date=14 October 2020)) ((PD-notice))</ref>

== 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.<ref name="FDA PR" />

== Pharmacology ==
=== Mechanism of action ===
[[File:Ebola Virus - Electron Micrograph.tiff|thumb|250 px|Colorized scanning electron micrograph of Ebola virus particles (green)]]
Atoltivimab/maftivimab/odesivimab is a combination of ''Zaire ebolavirus'' glycoprotein-directed human monoclonal antibodies.<ref name="FDA PR" /> The three antibodies target the [[glycoprotein]] that is on the surface of the Ebola virus.<ref name="FDA PR" /> This glycoprotein normally attaches to the cell via a receptor and fuses the viral and host cell membranes allowing the virus to enter the cell.<ref name="FDA PR" /> The antibodies can bind to it simultaneously at three different locations and block attachment and entry of the virus.<ref name="FDA PR" />

This combination drug targets the Zaire species of Ebola virus. The Sudan and [[Bundibugyo]] strains have also caused outbreaks, and it is unlikely that it would be effective against these strains.<ref name="futurity">((cite web |title=Ebola Treatment Massively Cuts Death Rate, But It's No Cure |url=https://www.futurity.org/regn-eb3-ebola-treatment-trial-2135642/ |website=Futurity |accessdate=7 November 2019|date=2019-08-16 ))</ref>

== History ==
=== Early development ===
The 2014 Ebola outbreak killed more than 11,300 people. Regeneron used its VelociGene, VelocImmune and VelociMab antibody discovery and production technologies and coordinated with the U.S. government's [[Biomedical Advanced Research and Development Authority]] (BARDA).<ref name="Hoping">((cite web|last1=Stahl|first1=Niel|title=Making a Drug You Hope No One Will Ever Need Harnessing the Power of Technology for Good|url=https://www.regeneron.com/perspectives/making-ebola-drug|accessdate=6 November 2019))</ref>  The therapy was developed in six months and a Phase 1 trial in healthy humans was completed in 2015.<ref name="Hoping"/>

=== PALM trial ===
((cleanup|section|reason=Merged from [[REGN-EB3]]; needs a consistent time line.|date=March 2021))
During the [[2018 Équateur province Ebola outbreak]], a similar monoclonal antibody treatment, [[mAb114]], was requested by the Democratic Republic of Congo (DRC) Ministry of Public Health. mAb114 was approved for [[compassionate use]] by the [[World Health Organization]] [[Monitored Emergency Use of Unregistered and Investigational Interventions|MEURI]] ethical protocol and at DRC ethics board. mAb114 was sent along with other therapeutic agents to the outbreak sites.<ref>((cite journal|last=Check Hayden|first=Erika|date=May 2018|title=Experimental drugs poised for use in Ebola outbreak|journal=Nature|volume=557|issue=7706|pages=475–476|doi=10.1038/d41586-018-05205-x|pmid=29789732|issn=0028-0836|bibcode=2018Natur.557..475C|doi-access=free))</ref><ref>WHO: Consultation on Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola virus Disease. https://www.who.int/emergencies/ebola/MEURI-Ebola.pdf</ref><ref name=":6" /> However, the outbreak came to a conclusion before any therapeutic agents were given to patients.<ref name=":6">((cite web|url=https://videocast.nih.gov/summary.asp?Live=31594&bhcp=1|title=NIH VideoCast - CC Grand Rounds: Response to an Outbreak: Ebola Virus Monoclonal Antibody (mAb114) Rapid Clinical Development|website=videocast.nih.gov|date=13 March 2019 |access-date=2019-08-09))</ref>

Approximately one month following the conclusion of the Équateur province outbreak, a distinct outbreak was noted in [[Kivu]] in the DRC ([[2018–20 Kivu Ebola epidemic|2018–20 Kivu Ebola outbreak]]). Once again, mAb114 received approval for compassionate use by WHO MEURI and DRC ethic boards and has been given to many patients under these protocols.<ref name=":6" /> In November 2018, the Pamoja Tulinde Maisha (PALM [together save lives]) open-label randomized clinical control trial was begun at multiple treatment units testing mAb114, REGN-EB3 and [[remdesivir]] to [[ZMapp]]. Despite the difficulty of running a clinical trial in a conflict zone, investigators have enrolled 681 patients towards their goal of 725.((cn|date=January 2023))

This is the second largest outbreak with (as of January 2020) over 3,400 confirmed or probable cases, including more than 2,200 who have died.<ref name="Nature">((cite news |title=Two Ebola drugs show promise amid ongoing outbreak |url=https://www.nature.com/articles/d41586-019-02442-6 |accessdate=6 November 2019 |agency=Nature))</ref><ref>((cite web|url=https://www.who.int/csr/don/23-january-2020-ebola-drc/en/ |archive-url=https://web.archive.org/web/20200305130047/https://www.who.int/csr/don/23-january-2020-ebola-drc/en/ |url-status=dead |archive-date=5 March 2020 |title=Ebola virus disease – Democratic Republic of the Congo  |publisher=WHO |date=23 January 2020 |accessdate=28 January 2020))</ref>

An interim analysis by the Data Safety and Monitoring Board (DSMB) of the first 499 patient found that mAb114 and REGN-EB3 were superior to the comparator [[ZMapp]]. Overall mortality of patients in the ZMapp and Remdesivir groups were 49% and 53% compared to 34% and 29% for mAb114 and REGN-EB3. When looking at patients who arrived early after disease symptoms appeared, survival was 89% for mAB114 and 94% for REGN-EB3.  While the study was not [[Power (statistics)|powered]] to determine whether there is any difference between REGN-EB3 and mAb114, the survival difference between those two therapies and ZMapp was significant. This led to the DSMB halting the study and PALM investigators dropping the remdesivir and ZMapp arms from the clinical trial. All patients in the outbreak who elect to participate in the trial will now be given either mAb114 or REGN-EB3.<ref>((cite web|url=https://arstechnica.com/science/2019/08/two-ebola-drugs-boost-survival-rates-according-to-early-trial-data/|title=Two Ebola drugs boost survival rates, according to early trial data|last=Mole|first=Beth|date=2019-08-13|website=Ars Technica|access-date=2019-08-17))</ref><ref>((cite web|url=https://www.nih.gov/news-events/news-releases/independent-monitoring-board-recommends-early-termination-ebola-therapeutics-trial-drc-because-favorable-results-two-four-candidates|title=Independent monitoring board recommends early termination of Ebola therapeutics trial in DRC because of favorable results with two of four candidates|date=2019-08-12|website=National Institutes of Health (NIH)|access-date=2019-08-17))</ref><ref name="McNeilNYT" /><ref name=":7">((cite web|url=http://www.theafricareport.com/Central-Africa/congos-experimental-mab114-ebola-treatment-appears-successful-authorities.html|title=Congo's experimental mAb114 Ebola treatment appears successful: authorities ((!)) Central Africa|last=Kingsley-Hall|first=Alison |website=www.theafricareport.com|access-date=2018-10-15))</ref>

In August 2019, Congolese health officials announced it was more effective compared to two other treatments being used at the time.<ref>((cite news|url=https://www.npr.org/2018/11/27/670913385/ebola-treatment-trials-launched-in-democratic-republic-of-the-congo-amid-outbrea|title=Ebola Treatment Trials Launched In Democratic Republic Of The Congo Amid Outbreak|website=NPR.org|date=27 November 2018|language=en|access-date=2019-05-28|last1=Dwyer|first1=Colin))</ref><ref name=McNeilNYT>((cite news |last=McNeil |first=Donald G. |author-link=Donald McNeil, Jr. |date=12 August 2019 |title=A Cure for Ebola? Two New Treatments Prove Highly Effective in Congo |url=https://www.nytimes.com/2019/08/12/health/ebola-outbreak-cure.html |work=The New York Times |access-date=13 August 2019 ))</ref><ref name=MolteniWired>((cite magazine |last=Molteni |first=Megan |date=12 August 2019 |title=Ebola is Now Curable. Here's How The New Treatments Work |url=https://www.wired.com/story/ebola-is-now-curable-heres-how-the-new-treatments-work/ |magazine=Wired |access-date=13 August 2019 ))</ref>

Among patients treated with it, 34% died; the mortality rate improved if the drug was administered soon after infection, in a timely diagnosis – critical for those infected with diseases like Ebola that can cause [[sepsis]] and, eventually, [[multiple organ dysfunction syndrome]], more quickly than other diseases.<ref>((cite web | url=https://www.msn.com/en-us/news/world/ebola-is-now-a-disease-we-can-treat-how-a-cure-emerged-from-a-war-zone/ar-AAJA1MI?ocid=spartanntp |title = 'Ebola is Now a Disease We Can Treat.' How a Cure Emerged from a War Zone|website = [[MSN]]))</ref>  The survival rate if the drug was administered shortly after the infection was 89%.<ref name="Nature"/>

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.<ref name="FDA PR" /><ref name="FDA snapshot" /> 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.<ref name="FDA PR" /> The trial enrolled pediatric and adult participants (including pregnant women) with Zaire ebolavirus infection.<ref name="FDA snapshot" /> All participants received standard, supportive care for the disease.<ref name="FDA snapshot" /> The participants and the health care providers knew which treatment was being given.<ref name="FDA snapshot" /> The primary efficacy endpoint was 28-day mortality.<ref name="FDA PR" /> 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.<ref name="FDA PR" /> 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.<ref name="FDA PR" /> In the expanded access program, an additional 228 participants received atoltivimab/maftivimab/odesivimab.<ref name="FDA PR" />

=== Regulatory status ===
The FDA granted the application of atoltivimab/maftivimab/odesivimab-ebgn [[orphan drug]] and [[breakthrough therapy]] designations.<ref name="FDA PR" /> The FDA granted the approval of Inmazeb to Regeneron Pharmaceuticals with an [[Indication (medicine)|indication]] for the treatment of infection caused by ''Zaire ebolavirus'' in October 2020.<ref name="FDA PR" /><ref name="Drug Approval Package" />

The drug has also received orphan drug designation from the [[European Medicines Agency]].<ref name="PALM PR">((cite web |title=Palm Ebola Clinical Trial Stopped Early As Regeneron's REGN-EB3 Therapy Shows Superiority to ZMAPP in Preventing Ebola Deaths |url=https://newsroom.regeneron.com/news-releases/news-release-details/palm-ebola-clinical-trial-stopped-early-regenerons-regn-eb3 |website=Regeneron |accessdate=6 November 2019))</ref>

== References ==
((reflist))

== Further reading ==
((refbegin))
* ((cite journal | vauthors = Mulangu S, Dodd LE, Davey RT, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallée D, Nordwall J | title = A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics | journal = The New England Journal of Medicine | volume = 381 | issue = 24 | pages = 2293–2303 | date = December 2019 | pmid = 31774950 | doi = 10.1056/NEJMoa1910993 | doi-access = free | pmc = 10680050 ))
* ((cite journal | vauthors = Sivapalasingam S, Kamal M, Slim R, Hosain R, Shao W, Stoltz R, Yen J, Pologe LG, Cao Y, Partridge M, Sumner G, Lipsich L | title = Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study | journal = The Lancet. Infectious Diseases | volume = 18 | issue = 8 | pages = 884–893 | date = August 2018 | pmid = 29929783 | doi = 10.1016/S1473-3099(18)30397-9 | s2cid = 49345203 ))
((refend))

== External links ==
* ((ClinicalTrialsGov|NCT03719586|Investigational Therapeutics for the Treatment of People With Ebola Virus Disease))
* ((cite web | title=Making a Drug You Hope No One Will Ever Need | website=Regeneron Pharmaceuticals | url=https://www.regeneron.com/perspectives/making-ebola-drug ))

((Monoclonals for infectious disease and toxins))
((Portal bar | Medicine | Viruses))
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((DEFAULTSORT:Atoltivimab Maftivimab Odesivimab))
[[Category:Combination antiviral drugs]]
[[Category:Ebola]]
[[Category:Monoclonal antibodies]]
[[Category:Orphan drugs]]
[[Category:Regeneron Pharmaceuticals]]
[[Category:World Health Organization essential medicines]]

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Template:Plainlist (view source) (protected)
Template:Plainlist/styles.css (view source) (protected)
Template:Portal bar (view source) (template editor protected)
Template:Refbegin (view source) (template editor protected)
Template:Refbegin/styles.css (view source) (template editor protected)
Template:Refend (view source) (template editor protected)
Template:Reflist (view source) (protected)
Template:Reflist/styles.css (view source) (protected)
Template:SDcat (view source) (protected)
Template:Short description (view source) (protected)
Template:Short description/lowercasecheck (view source) (protected)
Template:Source-attribution (view source) (template editor protected)
Template:Template other (view source) (protected)
Template:Terminate sentence (view source) (template editor protected)
Template:Unbulleted list (view source) (template editor protected)
Template:Use American English (view source) (template editor protected)
Template:Use dmy dates (view source) (template editor protected)
Template:Yesno (view source) (protected)
Module:Arguments (view source) (protected)
Module:Authority control (view source) (template editor protected)
Module:Authority control/config (view source) (template editor protected)
Module:Category handler (view source) (protected)
Module:Category handler/blacklist (view source) (protected)
Module:Category handler/config (view source) (protected)
Module:Category handler/data (view source) (protected)
Module:Category handler/shared (view source) (protected)
Module:Check for unknown parameters (view source) (protected)
Module:Citation/CS1 (view source) (protected)
Module:Citation/CS1/COinS (view source) (protected)
Module:Citation/CS1/Configuration (view source) (protected)
Module:Citation/CS1/Date validation (view source) (protected)
Module:Citation/CS1/Identifiers (view source) (protected)
Module:Citation/CS1/Utilities (view source) (protected)
Module:Citation/CS1/Whitelist (view source) (protected)
Module:Citation/CS1/styles.css (view source) (protected)
Module:Delink (view source) (protected)
Module:Disambiguation/templates (view source) (protected)
Module:Engvar (view source) (template editor protected)
Module:Infobox (view source) (template editor protected)
Module:Infobox/styles.css (view source) (template editor protected)
Module:InfoboxImage (view source) (template editor protected)
Module:List (view source) (protected)
Module:Message box (view source) (protected)
Module:Message box/ambox.css (view source) (protected)
Module:Message box/configuration (view source) (protected)
Module:Namespace detect/config (view source) (protected)
Module:Namespace detect/data (view source) (protected)
Module:Navbar (view source) (protected)
Module:Navbar/configuration (view source) (protected)
Module:Navbar/styles.css (view source) (protected)
Module:Navbox (view source) (template editor protected)
Module:Navbox/configuration (view source) (template editor protected)
Module:Navbox/styles.css (view source) (template editor protected)
Module:Ns has subpages (view source) (protected)
Module:Pagetype (view source) (protected)
Module:Pagetype/config (view source) (protected)
Module:Pagetype/disambiguation (view source) (protected)
Module:Pagetype/rfd (view source) (template editor protected)
Module:Pagetype/setindex (view source) (protected)
Module:Pagetype/softredirect (view source) (protected)
Module:ParameterCount (view source) (template editor protected)
Module:Portal (view source) (template editor protected)
Module:Portal/images/m (view source) (template editor protected)
Module:Portal/images/v (view source) (template editor protected)
Module:Portal bar (view source) (template editor protected)
Module:Portal bar/styles.css (view source) (template editor protected)
Module:SDcat (view source) (protected)
Module:String (view source) (protected)
Module:TableTools (view source) (protected)
Module:TemplatePar (view source) (template editor protected)
Module:Text (view source) (template editor protected)
Module:Unstrip (view source) (template editor protected)
Module:Unsubst (view source) (protected)
Module:Wikitext Parsing (view source) (protected)
Module:Yesno (view source) (protected)

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