Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 139 |
| INN | Brolucizumab |
| Status | Approved |
| Drug code(s) | RTH258, ESBA1008, DLX-1008 |
| Brand name | BEOVU® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | scFv |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit B cell derived |
| Target(s) | VEGF |
| Indications of clinical studies | Diabetic macular edema, Neovascular Age-related Macular Degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2010 |
| Start of Phase 2 | March 15, 2013 |
| Start of Phase 3 | December 15, 2014 |
| Date BLA/NDA submitted to FDA | February 07, 2019 |
| Year of first approval (global) | 2019 |
| Date of first US approval | October 08, 2019 |
| INN, US product name | Brolucizumab, brolucizumab-dbll |
| US or EU approved indications | Wet Age-Related Macular Degeneration |
| Company | Novartis Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Approval in EU announced by Novartis on Feb 18, 2020. NCT04058067 Phase 3 in diabetic macular edema not yet recruiting as of Aug 15, 2019. BLA in review by mid-April 2019. Novartis used a priority review voucher to expedite FDA review and anticipates launching brolucizumab, if approved by the FDA, by the end of this year. Appears in March 2019 medicines in evaluation report from EMA, which was compiled on March 15, 2019. July 2018: BLA submission planned for H2 2018. NCT03481634 Phase 3 study recruiting and NCT03481660 Phase 3 study in DME started in July 2018. June 2017: RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints. These pivotal studies enrolled more than 1,800 patients with neovascular age-related macular degeneration. Three Phase 3 studies on-going as of Sep 2015; one has completion date in 2016. 2009: ESBATech sold its ophthalmic business for USD 589M to Alcon, the leader in eye care. Shortly thereafter, Alcon was acquired by Novartis. |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
immunoglobulin scFv, anti-[Homo sapiens VEGFA (vascular endothelial growth factor A, VEGF-A, VEGF)], humanized monoclonal antibody single chain; scFv (1-252) [methionyl (1) -humanized V-KAPPA (Homo sapiens IGKV1-5*01 (87.60%)-IGKJ2*01 E125>T (108), I126>V (109), K127>L (110) [6.3.12] (2111) -21-mer (glycyl-tetrakis(tetraglycyl-seryl)) linker (112132) -humanized VH (Homo sapiens IGHV3-66*01 (80.40%)-(IGHD)-IGHJ1*01 [9.7.13] (133-252) angiogenesis inhibitor. 26 kDa molecule with potent inhibition of, and high affinity to all VEGF-A isoforms
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |