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Efgartigimod alfa and hyaluronidase

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Vyvgart hytrulo, Efgartigimod alfa and hyaluronidase-qvfc

ARGENX SE ARGX

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    0

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761304,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
ARGENX SE ARGX Source: Company record for ARGENX SE (opens in a new tab)
Indications
Not recorded
Application
BLA 761304 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761304 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Completed
  5. Filed Completed
  6. Approved Current stageFirst approval 20 Jun 2023

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Efgartigimod alfa and hyaluronidase. Editors add each one with its source.

Filed application

No filed application is on record for Efgartigimod alfa and hyaluronidase. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Efgartigimod alfa and hyaluronidase.

Clinical trials

No trials are linked to this drug yet.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Efgartigimod alfa and hyaluronidase, newest first
ApplicationActionDateOutcomeReviewSource
BLA761304Action letter for BLA761304 (opens in a new tab) Supplement 18 EfficacyApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)
BLA761304Action letter for BLA761304 (opens in a new tab) Supplement 10 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761304Action letter for BLA761304 (opens in a new tab) Supplement 8 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761304Action letter for BLA761304 (opens in a new tab) Supplement 3 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761304Action letter for BLA761304 (opens in a new tab) Supplement 5 EfficacyApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)
BLA761304Action letter for BLA761304 (opens in a new tab) Original 1 UNKNOWNApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Efgartigimod alfa and hyaluronidase.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.