Nucala

Treats severe asthma and with an eosinophilic phenotype. BLA 125526, held by Glaxosmithkline LLC. Mepolizumab.

As of Nov 13, 2026, BLA 125526 (Nucala), held by Glaxosmithkline LLC, was first approved by FDA on Nov 4, 2015, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2015
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:

Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype.
Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 22, 2025	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 29, 2021	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2020	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 12, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Other
Dec 12, 2017	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 4, 2015	Original applicationNew molecular entity · Standard review	Approved	Pediatric Clinical Pharmacology Review Review Summary Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nucala100MG · injectable;subcutaneous lyophilized power	Mepolizumab	Rx

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 22, 2025	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 8, 2023	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 22, 2022	Supplement 19Labeling · Standard review	Approved	Label Letter
Jul 29, 2021	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2020	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 12, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Other
Jun 6, 2019	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 12, 2017	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 16, 2017	Supplement 2Labeling · Standard review	Approved	Label
Nov 4, 2015	Original applicationNew molecular entity · Standard review	Approved	Pediatric Clinical Pharmacology Review Review Summary Review Letter

Identifiers

Application: BLA 125526
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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