Belimumab · Regulatory label update

FDA supplemental approval: Benlysta (Labeling)

U.S. Food and Drug Administration · August 21, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval for a labeling change to belimumab (Benlysta), a biologic for systemic lupus erythematosus. The record confirms regulatory authorization of the label modification but contains no clinical efficacy, safety, or comparative trial data.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental BLA761043 for belimumab on 2026-08-21 Submission class: labeling change Product: Benlysta injectable injection, 200 mg/mL formulation

Safety

This record does not contain clinical trial results, efficacy data, safety data, or comparative benefit information.

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 belimumab; regulatory action affecting product information but does not report clinical trial efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-21

Application numberBLA761043

Formulation strength200 mg/mL

Caveats

This record does not contain clinical trial results, efficacy data, safety data, or comparative benefit information.
The specific labeling changes are not detailed in this regulatory record.
No patient population, sample size, or clinical endpoints are reported.
The record confirms approval status only; clinical rationale requires access to the full labeling document or the underlying BLA.

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 record; no clinical study design reported.

Directness

insufficient

Labeling change only; no clinical outcome data provided.

Consistency

insufficient

Single regulatory action; no comparative or replication data.

Risk of bias

insufficient

Regulatory approval process; clinical trial quality not described.

Sample adequacy

insufficient

No patient population or sample size reported in this record.

Source abstract

Drugs@FDA record for application BLA761043. This is a regulatory action record, not a clinical study. Brand name: BENLYSTA. Active ingredient: BELIMUMAB. Sponsor: GLAXOSMITHKLINE LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-21. Products: BENLYSTA, INJECTABLE, INJECTION, BELIMUMAB 200MG/ML.

Follow from this

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

BelimumabGlaxosmithkline