Hemlibra

For hemophilia A (congenital factor VIII deficiency) with or without factor VIII…. BLA 761083, held by Genentech Inc. Emicizumab.

As of Nov 13, 2026, BLA 761083 (Hemlibra), held by Genentech Inc, was first approved by FDA on Nov 16, 2017, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 16, 2017
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 4, 2018	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 4, 2018	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

4 strengths and forms

Product	Active ingredient	Marketing
Hemlibra30MG/ML · injectable;injection	Emicizumab	Rx
Hemlibra60MG/0.4ML · injectable;injection	Emicizumab	Rx
Hemlibra105MG/0.7ML · injectable;injection	Emicizumab	Rx
Hemlibra150MG · injectable;injection	Emicizumab	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 8, 2025	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Jan 31, 2024	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 6, 2022	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 16, 2021	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 2, 2021	Supplement 11Labeling · Standard review	Approved	Label Letter
Oct 4, 2018	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 4, 2018	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: BLA 761083
Drugs@FDA: Overview at FDA
Company: Genentech

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