Taltz

Treats moderate-to-severe plaque psoriasis. BLA 125521, held by Eli Lilly And Co. Ixekizumab.

As of Nov 13, 2026, BLA 125521 (Taltz), held by Eli Lilly And Co, was first approved by FDA on Mar 22, 2016, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2016
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TALTZ is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. adults with active psoriatic arthritis. adults with active ankylosing spondylitis. adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. 1.1 Plaque Psoriasis TALTZ is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 4, 2022	Supplement 23Efficacy (new indication or use) · Standard review	Approved	None posted
May 29, 2020	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 26, 2020	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Other
Aug 23, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 1, 2017	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 22, 2016	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Taltz80MG/ML · injectable;injection	Ixekizumab	Rx

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 20, 2024	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 20, 2023	Supplement 31Manufacturing	Tentative approval	Label Letter
Sep 13, 2023	Supplement 28Labeling · Standard review	Approved	Letter
Jul 27, 2022	Supplement 24Labeling · Standard review	Approved	Letter Label Medication Guide
May 4, 2022	Supplement 23Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 10, 2021	Supplement 14Labeling · Standard review	Approved	Label Letter
May 29, 2020	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 26, 2020	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Other
Aug 23, 2019	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 19, 2018	Supplement 2	Approved	Letter Label
Mar 16, 2018	Supplement 11Labeling · Standard review	Approved	Letter
Dec 1, 2017	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 5, 2017	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 22, 2016	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: BLA 125521
Drugs@FDA: Overview at FDA
Company: Eli Lilly

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