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
-

Acelyrin stock plunges after positive Phase II data readout in thyroid eye disease

Acelyrin's Phase II trial for lonigutamab in thyroid eye disease showed symptom improvements but led to a 36% stock drop. The drug may be safer than Tepezza, with Phase III trials planned. Lonigutamab, a potential Tepezza competitor, could generate $624m by 2030 if approved.

Acelyrin To Take Tepezza Competitor Into Phase III In TED

Acelyrin advances lonigutamab to Phase III for thyroid eye disease, facing competition from Tepezza and Viridian's Phase III candidate.

Acelyrin To Take Tepezza Competitor Into Phase III In Thyroid Eye Disease

Acelyrin advances lonigutamab to Phase III for thyroid eye disease, facing competition from Tepezza and Viridian's Phase III candidate.

Targeting IL-6 inflammation: A promising frontier in treating thyroid eye disease

Thyroid eye disease (TED) treatment is advancing with IL-6 targeting therapies like pacibekitug, aiming for durable disease control by addressing autoimmune inflammation's root causes, beyond current symptom-focused treatments.
finance.yahoo.com
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Viridian Therapeutics sees stock soar after Phase III TED success

Viridian Therapeutics' stock surged after its Phase III trial of veligrotug met all endpoints, showing a 56% proptosis responder rate and a 2.34mm mean reduction in proptosis in chronic thyroid eye disease patients. The treatment also achieved a 56% diplopia response rate, with 32% complete resolution, compared to 14% in placebo patients.

Viridian Continues Building Case For Veligrotug In TED

Viridian's veligrotug meets efficacy and safety endpoints in active and chronic TED patients, offering less burdensome dosing compared to Amgen’s Tepezza.
investing.com
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Amgen's SWOT analysis: obesity program drives stock outlook

Amgen Inc., a biopharmaceutical leader, shows strong financial health and revenue growth. Its obesity treatment, MariTide, and cardiometabolic portfolio are key growth drivers. Despite mixed product performance, Amgen's robust pipeline and strategic initiatives offer significant growth potential, though risks include clinical trial failures and market competition.
biospace.com
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Amgen Whets Investors' Appetites for MariTide Obesity Data by End of Year

Amgen's Q3 earnings report showed $8.5 billion in revenue, 23% YoY growth, with non-GAAP EPS at $5.58, beating estimates. Key products like Blincyto and Repatha saw significant growth, while Tepezza and Prolia missed expectations. MariTide Phase II study is progressing, with data expected later this year.

Amgen earns higher revenues in Q3 2024, puts rare diseases in the spotlight

Amgen's Q3 2024 revenue surged 23% to $8.5bn, driven by 24% product sales growth, including ten double-digit growth products. The innovative oncology portfolio grew 17%, and the rare disease portfolio saw a 21% YOY increase to $1.2bn, boosted by Horizon Therapeutics' acquisitions. Amgen discontinued the LPAR1 antagonist study due to Phase II failure but plans to share Phase II MariTide data in late 2024 and initiate a Phase III program for obesity and T2D.
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