Efgartigimod alfa
Also known as Vyvgart
ARGENX SE ARGX
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
BLA761195,
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
- Applications
- BLA 761195 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761195 (opens in a new tab)
- 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
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Completed
- Filed Completed
- Approved Current stageFirst approval 17 Dec 2021
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
Efgartigimod alfaPDUFAOccurred
Zai Lab Ltd: PDUFA date in 10-K filed 26 February 2026
We participated in the study in Greater China. In January 2026, the FDA accepted for priority review an sBLA submitted by argenx seeking expansion of the VYVGART label to include adult AChR-Ab sn-gMG patients with a PDUFA target action date of May 10, 2026.
176days ago
FDA designations
No FDA designations are on record for Efgartigimod alfa. Editors add each one with its source.
Filed application
No filed application is on record for Efgartigimod alfa. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Efgartigimod alfa.
Clinical trials
No trials are linked to this drug yet.
Trial quality
About CT-VCALoading trial quality…
FDA actions
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)
AuthorisedOrphan medicine
Vyvgart (EMEA/H/C/005849)
- Authorised
- Therapeutic area
- Myasthenia Gravis;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Marketing authorisation holder
- Argenx
- Active substance (INN)
- efgartigimod alfa
- ATC code
- L04AA58
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Vyvgart (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761195 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- Drugs@FDA via openFDA BLA761195 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA BLA761304 (opens in a new tab) Licence: cc0. Fetched
- 0001704292-26-000015 (opens in a new tab) Licence: public-domain. Entered by an editor, not fetched automatically
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.