Vabysmo

BLA 761235, held by Genentech Inc. Faricimab-Svoa.

As of Nov 13, 2026, BLA 761235 (Vabysmo), held by Genentech Inc, was first approved by FDA on Jan 28, 2022, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2022
Review: Priority
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Diabetic Macular Edema (DME) Macular Edema Following Retinal Vein Occlusion (RVO) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 9, 2026	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 26, 2023	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2023	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 28, 2022	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vabysmo120MG/ML · injectable; intravitreal	Faricimab-Svoa	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 9, 2026	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 3, 2024	Supplement 5Manufacturing	Approved	Label Letter
Oct 26, 2023	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2023	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 28, 2022	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: BLA 761235
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