Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 137 |
| INN | Faricimab |
| Status | Approved |
| Drug code(s) | RO6867461, RG7716 |
| Brand name | Vabysmo |
| mAb sequence source | mAb humanized/human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | 1+1 CrossMab |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display for initial discovery and affinity maturation |
| Target(s) | Ang-2, VEGF |
| Indications of clinical studies | Wet age-related macular degeneration, Choroidal Neovascularization, Diabetic Macular Edema |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 29, 2013 |
| Start of Phase 2 | August 11, 2015 |
| Start of Phase 3 | September 05, 2018 |
| Date BLA/NDA submitted to FDA | May 28, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | January 28, 2022 |
| INN, US product name | Faricimab, faricimab-svoa |
| US or EU approved indications | Supp. US approval: Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion. Treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema. |
| Company | Hoffmann-La Roche |
| Licensee/Partner | None |
| Comments about company or candidate | January 28, 2022: Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo ™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). MAA in EMA review as of June 2021. June 11, 2021 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed a new drug application with the Ministry of Health, Labour and Welfare (MHLW) for faricimab, the anti VEGF/anti Ang-2 bispecific antibody, for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) on June 10, 2021. NCT04777201 Phase 3 due to start in April 2021. NCT04432831 Phase 3 in Diabetic Macular Edema started in Aug 2020. Phase 3 LUCERNE study (NCT03823300) and Phase 3 TENAYA study (NCT03823287) started recruiting in March and Feb 2019, respectively. Oct 2018: Roche announced results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of neovascular (wet) age-related macular degeneration (nAMD). Results of the study were presented as a late-breaking oral presentation titled "Simultaneous Inhibition of VEGF and Ang-2 with Faricimab in Neovascular AMD: STAIRWAY Phase 2 Results" during the 2018 American Academy of Ophthalmology’s (AAO) Annual Meeting on October 27, 2018. Sep 2018: Roche announced that it has initiated the Phase III YOSEMITE and RHINE studies of faricimab compared to aflibercept in diabetic macular edema. NCT03622580 Phase 3 study in Diabetic Macular Edema recruiting as of Sep 2018. NCT03622593 Phase 3 study recruiting as of Oct 9 2018. Feb 2018: Positive results from Phase 2 BOULEVARD study. RG7716 is also being evaluated in the Phase II AVENUE and STAIRWAY studies in neovascular age-related macular degeneration (nAMD). All three studies have finished enrolment and are currently in follow-up. Roche is committed to presenting data from all Phase II studies at upcoming medical meetings, and we plan to discuss our Phase III programme with health authorities following data assessment. Listed as Phase 2 in Q3 2015 update of Roche pipeline; still listed as Phase 2 in Q3 2017 pipeline update. NCT01941082 Phase 1 study completed as of Feb 2016. IND received Aug 29, 2013 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761235Orig1s000MedR.pdf] |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
CrossMab with Fc engineering; not the same molecule as the CrossMab for cancer. Optimized Fc for faster systemic clearance (FcRn), no effector function (FcγR); parental components targeting VEGF‐A (ranibizumab) and ANG‐2 (LC10; RO5485202) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5090659/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |