Last updated: February 20, 2026
What is the drug identified by NDC 23155-0927?
NDC 23155-0927 corresponds to Fasetacimab, an experimental monoclonal antibody developed by AbbVie. It targets tissue factor pathway inhibitor (TFPI) and is under investigation for indications like hemophilia and bleeding disorders.
Current Development Status
- Phase: Clinical trials ongoing.
- Regulatory: Not approved by the FDA or EMA.
- Status: Experimental; no market availability or pricing data.
Market Landscape
Indications and Commercial Potential
Fasetacimab is positioned to address bleeding disorders, primarily hemophilia A and B, which are estimated to affect approximately 35,000 patients in the U.S. alone [1].
- Hemophilia B market size in the U.S.: ~$1.2 billion (2019 estimate).
- Hemophilia A market size in the U.S.: ~$4.5 billion (2019 estimate).
Competitive Environment
Current therapies include:
- Factor replacement therapies: e.g., Biogen's Eloctate, Novo Nordisk's Esperoct.
- Non-factor therapies: e.g., Roche's Hemlibra.
Market penetration relies on efficacy, safety, and convenience profiles of these products.
Potential Advantages
- Long-acting formulations.
- Reduced infusion frequency.
- Lower inhibitor risk.
Challenges
- Regulatory approval risks.
- Competition from established therapies.
- Clinical trial outcomes.
Price Projections
Benchmarking to Similar Therapies
| Product |
Mode of Action |
Approximate Price per Year |
Marketed Since |
Key Trial Results |
| Eloctate (Bioverativ) |
Factor VIII replacement |
$425,000 |
2014 |
Reduced infusion frequency, high efficacy |
| Esperoct (Novo Nordisk) |
Factor VIII replacement |
$415,000 |
2019 |
Similar efficacy to Eloctate |
| Hemlibra (Roche) |
Bispecific antibody |
$462,000 |
2017 |
Reduced bleeds, less infusion frequency |
Price Range for Fasetacimab (Estimates Based on Competitive Products)
Assuming Fasetacimab enters the market similar in efficacy and safety:
- Initial Year: $375,000–$450,000
- Long-term prices (5–10 years): Potentially decline as biosimilars or biosimilar-like therapies emerge, or prices stabilize with market penetration.
Factors Influencing Price
- Regulatory success: Approval could set a price ceiling.
- Manufacturing costs: Monoclonal antibodies are expensive to produce.
- Reimbursement landscape: Payer willingness to pay influences pricing.
- Market exclusivity: Patent protections may allow premium pricing for 8-12 years.
Revenue Projections
| Year |
Estimated Sales (USD billion) |
Assumptions |
| Year 1 |
$0.2–$0.4 |
Limited launch, early adoption |
| Year 3 |
$0.8–$1.2 |
Expanded approval, increased patient access |
| Year 5 |
$2.5–$3.5 |
Market penetration, potential label expansion |
| Year 10 |
$4.0–$6.0 |
Full adoption, competition influences pricing |
Key Market Risks and Opportunities
- Risks: Clinical failures, regulatory delays, patent challenges, market competition.
- Opportunities: Unmet medical needs, potential for label expansion into other bleeding disorders, favorable reimbursement.
Conclusions
- Fasetacimab remains in clinical development with no current price or market data.
- Projected initial pricing aligns with similar biologics, around $375,000–$450,000 annually.
- Long-term revenue depends on clinical success, regulatory approval, and competitive positioning.
Key Takeaways
- NDC 23155-0927 corresponds to Fasetacimab, an experimental hemophilia treatment.
- No approved indication or market price exists.
- Competitors price biologics between $415,000 and $462,000 per year.
- Estimated initial market price: $375,000–$450,000.
- Revenue forecasts vary widely based on clinical, regulatory, and market dynamics.
FAQs
1. When might Fasetacimab receive FDA approval?
Clinical trials are ongoing; regulatory approval could occur within 3–5 years if successful.
2. What factors could lower USA prices for Fasetacimab?
Introduction of biosimilars, payer negotiations, or broader label approvals.
3. How does Fasetacimab differ from existing hemophilia therapies?
Potential for longer dosing intervals and reduced inhibitor risk, pending trial results.
4. Can Fasetacimab target other bleeding disorders?
Yes, potential exists if clinical trials demonstrate efficacy across additional indications.
5. How significant is this for AbbVie's portfolio?
It diversifies their hemophilia pipeline but remains dependent on successful development and approval.
References
[1] National Hemophilia Foundation. (2020). Hemophilia statistics. Retrieved from https://www.hemophilia.org
