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
- -
AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
Amgen reports Q3 2024 financial results: total revenues up 23% to $8.5 billion, GAAP EPS increased 62% to $5.22, non-GAAP EPS up 13% to $5.58, driven by strong product sales and pipeline investments.
Acelyrin Shifts Focus to Thyroid Eye Disease, Analysts Project Peak Sales
Acelyrin shifts focus from izokibep, despite positive PsA and HS trial results, to lonigutamab, a potential competitor to Amgen’s Tepezza for TED. Lonigutamab offers a subcutaneous advantage over Tepezza’s IV, with projected sales of $1.2 billion by 2038 amidst growing competition.
FTC's watchdog role in pharma mergers: Road bumps and the way forward
The FTC's 2023 revised merger guidelines impact pharmaceutical industries with stricter HHI and market share requirements, emphasizing direct evidence of market dominance and ecosystem competition. The FTC scrutinizes pharmaceutical mergers for market concentration, innovation, and entry barriers, with ongoing investigations into Novo Nordisk/Catalent and AbbVie/Cerevel mergers. The EC investigates Zoetis for potential abuse of dominance post-merger, and the FTC challenges fraudulent patents to prevent market monopolization. Pharmaceutical companies are increasingly merging with biotech firms to offset patent expirations and enhance product portfolios.
A Stock on the Move That's Blessed with a Promising Drug Pipeline
The Federal Reserve cut short-term interest rates, boosting stocks like Amgen Inc. (AMGN), which is launching new drugs including Lumakras and Tepezza. Amgen's MariTide, in phase two, shows potential in weight loss and diabetes treatment, with analyst projections of $2.1 billion in revenue by 2030. Amgen's pipeline includes over 30 phase 3 programs. Recommended action: Buy AMGN.
Tepezza approved in Japan for active thyroid eye disease
Amgen's TEPEZZA (teprotumumab) approved by Japan's Ministry of Health for active thyroid eye disease (TED), marking the first treatment in Japan for this condition. The approval is based on the OPTIC-J study, which showed significant improvement in proptosis with Tepezza treatment. TEPEZZA is also approved in the U.S., Brazil, and Saudi Arabia, with ongoing reviews in Europe, Canada, and Australia.
Lilly gets second approval, in Japan, for Alzheimer's drug
Eli Lilly's Alzheimer's drug Kisunla (donanemab) gains approval in Japan, following US FDA approval in July. Kisunla targets early symptomatic Alzheimer's, showing significant cognitive decline reduction in the TRAILBLAZER-ALZ 2 study. Japan's aging population makes it a key market, with dementia cases expected to reach 5 million by 2030, mostly Alzheimer's. Lilly emphasizes Kisunla's cost-effectiveness due to fixed treatment duration.
Amgen's TEPEZZA gets Japan's MHLW approval for thyroid eye disease treatment
Amgen receives approval from Japan’s MHLW for TEPEZZA to treat thyroid eye disease. The treatment involves eight infusions, with initial and subsequent doses at 10mg/kg and 20mg/kg respectively. The approval is based on the Phase III OPTIC-J trial, which showed 89% improvement in proptosis at week 24. A second Phase III trial is ongoing in Japan for chronic TED with low CAS.
TEPEZZA® (TEPROTUMUMAB) RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT
Amgen announces TEPEZZA® (teprotumumab) approval by Japan's MHLW for active Thyroid Eye Disease, marking the first approval in Asia. TEPEZZA is the only approved treatment in Japan for active TED, with a Phase 3 trial ongoing for chronic TED. The approval is based on the OPTIC-J study, showing 89% improvement in proptosis with TEPEZZA versus 11% with placebo.
Where Will Amgen Be in 5 Years?
Amgen's recent launches, like Lumakras, have underperformed, but the $28B Horizon acquisition could boost Tepezza sales. MariTide, in phase 2 for weight loss, shows promise. Amgen's pipeline includes over 30 phase 3 programs, aiming for label expansions and biosimilars. Despite recent slow organic growth, Tezspire's success and upcoming approvals suggest future growth. Amgen offers a 2.68% forward yield, making it a reliable dividend stock.
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.
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