Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 140 |
| INN | Teprotumumab |
| Status | Approved |
| Drug code(s) | RV001, RG1507 |
| Brand name | Tepezza |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | IGF-1R |
| Indications of clinical studies | Diffuse Cutaneous Systemic Sclerosis, Graves' Ophthalmopathy, Diabetic macular edema, Active thyroid eye disease (terminated for cancer indications Solid tumors, sarcoma, breast cancer, non-small cell lung cancer) |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 05, 2005 |
| Start of Phase 2 | November 15, 2007 |
| Start of Phase 3 | October 24, 2017 |
| Date BLA/NDA submitted to FDA | July 08, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | January 21, 2020 |
| INN, US product name | Teprotumumab, teprotumumab-trbw |
| US or EU approved indications | Treatment of adults with thyroid eye disease |
| Company | Hoffmann-La Roche |
| Licensee/Partner | Amgen |
| Comments about company or candidate | Sep 2024: Approved in Japan (https://www.prnewswire.com/news-releases/tepezza-teprotumumab-receives-approval-in-japan-for-the-treatment-of-active-thyroid-eye-disease-302257503.html) Sep 2019: The BLA was granted priority review and the PDUFA goal date is March 8, 2020. July 10 press release: BLA for treatment of active thyroid eye disease was submitted. Feb 2019: Horizon expects to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) in mid-2019. Teprotumumab has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. Detailed Phase III data will be submitted for publication in a peer-reviewed journal and presented at a medical congress later this year. NCT03461211 Phase 3 study started in April 2018. NCT03298867 Phase 3 study in Graves' Orbitopathy (Thyroid Eye Disease) start Oct 24 2017. Breakthrough therapy designation. Fast track designation granted in Sept 2015. Amgen acquired Horizon Therapeutics plc, which acquired Viela Bio (plan to acquire River Vision Development Corporation announced May 2017) Phase 2 NCT01868997 study started in May 2013 is recruiting as of June 2014; June 2013: River Vision Development Corp. (River Vision) announced that RV001, its human monoclonal antibody teprotumumab, has been granted Orphan Drug Designation by the FDA for the treatment of active phase Graves Orbitopathy (GO), also known as thyroid eye disease. Teprotumumab (R1507) was created by Genmab under a collaboration with Roche. Genmab will receive milestones as well as royalty payments on successful products. Clinical development of teprotumumab will be conducted by River Vision Development Corporation, who licensed the product from Roche. Teprotumumab infusion was submitted as IND 112952. Teprotumumab was granted orphan designation for the treatment of Active Thyroid Eye Disease on June 19, 2019 [12-3878/DRU201203878]. Teprotumumab received Fast Track designation in April 2015, and Breakthrough Therapy designation in July 2016. |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
Approved product produced in Chinese hamster ovary (CHO-DG44) cells.
| Anticipated events | Regulatory review EU, Canada and Australia |
| Factor(s) contributing to discontinuation | None |