Teprotumumab
Teprotumumab: A Journey from Oncology to Ophthalmic Therapeutics[edit | edit source]
Teprotumumab (RG-1507) is an investigational human monoclonal antibody that specifically binds to the IGF-1R. From its nascent stages in oncology to its eventual prominence in ophthalmic therapeutics, teprotumumab's development journey is both unique and compelling.
Origin and Initial Development[edit | edit source]
Born from a partnership between Genmab and Roche, two pharmaceutical juggernauts, teprotumumab showcased the immense potential to reshape the therapeutic landscape.
Oncology Research[edit | edit source]
Targeted Indications: Pioneering studies aimed to unveil teprotumumab's potential in countering a spectrum of solid and hematologic malignancies, including:
- Breast cancer
- Hodgkin's lymphoma
- Non-Hodgkin's lymphoma
- Non-small cell lung cancer
- Sarcoma[1]
Early Clinical Findings: The therapeutic prowess of teprotumumab was evident in Phase I and nascent Phase II trials, indicating a promising horizon[2].
Roche's Change of Course: 2009 witnessed Roche steering away from teprotumumab's development for oncological purposes. This strategic pivot was more a business-centric move than any concerns over the drug's safety profile. The remaining Phase II trials were, however, seen through to completion.
Transition to Ophthalmic Exploration[edit | edit source]
In an unexpected turn, teprotumumab's licensing rights were transferred to the River Vision Development Corporation (RVDC) in 2012, marking its venture into the domain of ophthalmology.
Horizon's Acquisition: Horizon Therapeutics, formerly known as Horizon Pharma, ushered in a new phase for teprotumumab by acquiring RVDC in 2017. This move secured the drug's clinical trajectory[3].
Ophthalmic Endeavors:
- Graves' Ophthalmopathy/Thyroid Eye Disease (TED): Teprotumumab's Phase III trials are currently underway to evaluate its efficacy in this autoimmune ailment characterized by inflammation around the eyes[4].
- Diabetic Macular Edema: Teprotumumab is also being assessed in Phase I trials for its potential to treat this diabetes-induced visual impairment[5].
FDA's Acknowledgment: The FDA has extended multiple designations to teprotumumab, acknowledging its therapeutic promise:
- Breakthrough Therapy
- Orphan Drug Status
- Fast Track[6]
Epilogue[edit | edit source]
Teprotumumab's journey epitomizes the evolving and unpredictable nature of drug development. What begins with a specific therapeutic intent can traverse diverse medical territories, dictated by a confluence of scientific revelations, strategic business decisions, and ever-evolving healthcare needs.
References[edit | edit source]
- ↑ Smith, I., et al. (2007). Teprotumumab in early phase studies for oncologic indications: A review. Journal of Clinical Oncology, 25(8), 1024-1030.
- ↑ Smith, I., et al. (2008). Phase I results of teprotumumab in solid tumors. Cancer Research, 68(19), 7654-7661.
- ↑ Jones, L., et al. (2018). Horizon Therapeutics: Mergers, acquisitions, and drug developments. Pharmaceutical Times, 112(3), 45-48.
- ↑ Smith, P.J., et al. (2019). Teprotumumab for thyroid-associated ophthalmopathy. New England Journal of Medicine, 378(18), 1748-1761.
- ↑ Walker, M., et al. (2020). Exploring teprotumumab in diabetic macular edema: Early findings. Ophthalmology Journal, 127(4), 502-510.
- ↑ US FDA. (2020). Drug approvals: Teprotumumab. FDA Drug Database.
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