MedPath

Teprotumumab

Generic Name
Teprotumumab
Brand Names
Tepezza
Drug Type
Biotech
Chemical Formula
-
CAS Number
1036734-93-6
Unique Ingredient Identifier
Y64GQ0KC0A
Background

Teprotumumab is a fully human IgG1 monoclonal antibody directed against the human insulin-like growth factor-1 receptor. Following a clinical trial in which its efficacy in the treatment of thyroid eye disease (TED) was assessed, it received "breakthrough therapy" designation from the FDA in 2016 and was approved by the FDA in January 2020 for the treatment of TED. Thyroid eye disease is a potentially debilitating complication of Graves' Disease involving inflammation and tissue remodeling behind the eye, and previous treatment options typically involved multiple invasive surgeries - teprotumumab is the first drug ever approved for the treatment of TED and therefore represents a significant step forward in the treatment this disease.

Indication

Teprotumumab is indicated for the treatment of thyroid eye disease regardless of disease activity or duration.

Associated Conditions
Thyroid Eye Disease
Associated Therapies
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Viridian Therapeutics' stock jumps after Phase III trial met all endpoints

Viridian Therapeutics' veligrotug met all primary and secondary endpoints in Phase III THRIVE trial for thyroid eye disease (TED), showing significant improvements in signs and symptoms. The treatment group had a 70% proptosis responder rate and 54% complete resolution of diplopia, compared to 5% and 12% in the placebo group, respectively. Veligrotug was generally well-tolerated, with no treatment-related serious adverse events. The company's stock price rose by 32% following the announcement.
biopharmadive.com
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Acelyrin shifts from main drug, lays off staff

Acelyrin shifts focus from izokibep to lonigutamab for thyroid eye disease, suspending further investments in izokibep despite positive trial results. The company cuts 43 jobs, aiming to extend cash runway to 2027 for lonigutamab's Phase 3 trials, amidst strategic restructuring.
finance.yahoo.com
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Decoding Amgen Inc (AMGN): A Strategic SWOT Insight

Amgen Inc showcases financial resilience with a 21.8% increase in Q1 2024 product sales, driven by strategic acquisitions like Horizon Therapeutics, enhancing its rare disease treatments. Despite facing regulatory pressures and operational complexities, opportunities in biosimilars and rare diseases offer growth potential amidst competitive and macroeconomic challenges.
fiercebiotech.com
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Acelyrin's proof-of-concept TED data cement Amgen

Acelyrin's lonigutamab shows promise in treating thyroid eye disease, matching Amgen’s Tepezza in severity improvement but with a lower response rate on eyeball protrusion. With no serious adverse events reported, Acelyrin plans further studies, aiming to compete in the TED market dominated by Tepezza.
biopharmadive.com
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Acelyrin eye drug heads to late-stage testing after trial win

Acelyrin plans late-stage testing for lonigutamab, a drug for thyroid eye disease, after positive Phase 2b/3 trial results. The drug showed clinically meaningful responses and was well-tolerated. Competing with Tepezza, lonigutamab offers a quicker, subcutaneous injection. Acelyrin's shares rose following the announcement.
labn.org
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Acelyrin reports Ph1/2 data on potential Tepezza competitor in thyroid eye disease

Acelyrin's experimental thyroid eye disease treatment showed symptom improvement in early-stage trial patients, potentially competing with Tepezza, the first approved medicine for the condition in 2020.
finance.yahoo.com
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Amgen (AMGN) Down 6.5% Since Last Earnings Report: Can It Rebound?

Amgen's Q4 2023 earnings beat estimates with $4.71 per share, driven by a 20% revenue increase to $8.2 billion, largely from product sales. Key drugs like Prolia and Repatha showed strong growth. However, shares dropped 6.5% post-earnings. Amgen expects 2024 revenues between $32.4 billion and $33.8 billion, with adjusted earnings of $18.90 to $20.30 per share, despite rising costs and a lower operating margin due to the Horizon acquisition.
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