Satralizumab · Regulatory label update

FDA supplemental approval: Enspryng (Manufacturing (CMC))

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

The FDA approved a supplemental application (CMC submission) for satralizumab (Enspryng) on 10 June 2026. This is a manufacturing or chemistry, manufacturing, and controls change to an already-approved drug product; it does not provide clinical efficacy, safety, or comparative trial data.

What was studied

Regulatory label update.

Key findings

Supplemental BLA761149 approved for Enspryng (satralizumab 120 mg/mL injectable injection) by Genentech on 2026-06-10 Submission class: Manufacturing (CMC)

Safety

This is a manufacturing (CMC) supplement only; no clinical trial results, efficacy data, safety outcomes, or comparative effectiveness data are reported or implied.

Who this may help

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

Plain-language summary

FDA supplemental approval for manufacturing changes to an approved drug; does not report clinical efficacy or trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-10

Product strength120 mg/mL

BLA number761149

Caveats

This is a manufacturing (CMC) supplement only; no clinical trial results, efficacy data, safety outcomes, or comparative effectiveness data are reported or implied.
The record does not state what manufacturing changes were approved.
No patient population, sample size, or clinical endpoints are included.

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 clinical study design present.

Directness

insufficient

Manufacturing approval; no clinical outcome data reported.

Consistency

insufficient

Single regulatory action; no comparative or replication data.

Risk of bias

insufficient

Regulatory filing; bias assessment not applicable.

Sample adequacy

insufficient

No patient sample; manufacturing compliance record only.

Source abstract

Drugs@FDA record for application BLA761149. This is a regulatory action record, not a clinical study. Brand name: ENSPRYNG. Active ingredient: SATRALIZUMAB. Sponsor: GENENTECH. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-06-10. Products: ENSPRYNG, INJECTABLE, INJECTION, SATRALIZUMAB 120MG/ML.

Follow from this

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

SatralizumabGenentech