Depemokimab · Regulatory label update

FDA supplemental approval: Exdensur (Labeling)

U.S. Food and Drug Administration · June 10, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is a regulatory action record documenting FDA approval of a supplemental labeling change for Exdensur (depemokimab 100 mg injection), approved 10 June 2026. The record does not contain clinical trial results, efficacy data, safety outcomes, or details of the labeling modification.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcome measures.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for labeling change to Exdensur (depemokimab); regulatory action does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-10

Dose and formulationDEPEMOKIMAB-ULAA 100MG, INJECTION

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcome measures.
The specific nature and content of the labeling change are not described in this record.
No patient population, sample size, or study design information is provided.
Approval does not convey comparative benefit or clinical evidence; consult full prescribing information for details.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action record; no study design described.

Directness

insufficient

Labeling supplement; clinical endpoints not reported.

Consistency

insufficient

No comparative or trial data provided in record.

Risk of bias

insufficient

Regulatory action record does not report trial methodology.

Sample adequacy

insufficient

No sample size or patient population data in record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application BLA761458. This is a regulatory action record, not a clinical study. Brand name: EXDENSUR. Active ingredient: DEPEMOKIMAB. Sponsor: GLAXOSMITHKLINE LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-10. Products: EXDENSUR, INJECTION, DEPEMOKIMAB-ULAA 100MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DepemokimabGlaxosmithkline