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maftivimab

Trade name: Inmazeb

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Oct 14, 2020

Clinical trial activity

0 trials · 0 clinical orgs · 2 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0

Timeline

2010s

  1. Jul 14, 2016

    Orphan Drug Designation

2020s

  1. Oct 14, 2020

    Regeneron — Earliest FDA Approval

  2. Oct 14, 2020

    Regeneron — Marketing Organization

  3. Oct 14, 2020

    Jazz Pharmaceuticals — Marketing Organization

  4. Oct 14, 2020

    Regeneron — NDA Secondary Org

  5. Oct 14, 2020

    Regeneron — NDA Organization

Indications

Approved for

Mechanism of action

  • EbolavirusANTAGONIST

    Ebolavirus antagonist

  • Envelope glycoproteinINHIBITOR

    Envelope glycoprotein inhibitor

    Binds to and inactivates the viral glycoprotein which mediates virus attachment to host cells. The viral glycoprotein is also expressed on the surface of virus-infected cells.

    In a viral-infected cell line, maftivimab neutralized Mayinga, Kikwit, and Makona strains of Zaire ebolavirus.

Combination products

Approval history

  • approvedPriority reviewBreakthroughOct 14, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Organizations

Marketing (4)

OrganizationOrg typeRelationshipDate
Jazz PharmaceuticalsFor profitMKTGOct 14, 2020
RegeneronFor profitMKTGOct 14, 2020
RegeneronFor profitNDA2Oct 14, 2020
RegeneronFor profitNDAOct 14, 2020