Benlysta

BLA 125370, held by Human Genome Sciences Inc.. Belimumab.

As of Nov 13, 2026, BLA 125370 (Benlysta), held by Human Genome Sciences Inc., was first approved by FDA on Mar 9, 2011, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 9, 2011
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BENLYSTA is indicated for the treatment of patients 5 years of age and older with:

Active systemic lupus erythematosus (SLE) who are receiving standard therapy
Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jul 26, 2022	Supplement 78Efficacy (new indication or use) · Priority review	Approved	Letter
Dec 16, 2020	Supplement 73Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 24, 2020	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 17, 2020	Supplement 68Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 26, 2019	Supplement 64Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Mar 9, 2011	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Benlysta120MG · injectable; injection	Belimumab	Rx
Benlysta400MG · injectable; injection	Belimumab	Rx

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 30, 2026	Supplement 89Labeling · Standard review	Approved	Letter Label
Aug 21, 2026	Supplement 90Labeling · Standard review	Approved	Letter Label
Jun 20, 2025	Supplement 85Labeling · Standard review	Approved	Letter Label Medication Guide
May 16, 2024	Supplement 81Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 9, 2024	Supplement 82Labeling · Standard review	Approved	Label Letter
Feb 15, 2023	Supplement 79Labeling · Standard review	Approved	Label Letter
Jul 26, 2022	Supplement 78Efficacy (new indication or use) · Priority review	Approved	Letter
Dec 16, 2020	Supplement 73Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 24, 2020	Supplement 71Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 17, 2020	Supplement 68Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 13, 2019	Supplement 67Labeling · Standard review	Approved	Letter Label
Apr 26, 2019	Supplement 64Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Jun 22, 2018	Supplement 62Labeling · Standard review	Approved	Label Letter
Jan 18, 2017	Supplement 57Labeling · Standard review	Approved	Letter Label
Dec 2, 2016	Supplement 55Labeling · Standard review	Approved	Letter Label
Apr 3, 2014	Supplement 53Labeling · Standard review	Approved	Label Letter
Dec 13, 2013	Supplement 47Labeling · Standard review	Approved	Letter Label
Mar 30, 2012	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 9, 2011	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: BLA 125370
Drugs@FDA: Overview at FDA
Company: Human Genome Sciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters