Inebilizumab-cdon - Biologic Drug Details

Summary for inebilizumab-cdon

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for inebilizumab-cdon

Mechanism of Action	CD19-directed Antibody Interactions
Established Pharmacologic Class	CD19-directed Cytolytic Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for inebilizumab-cdon Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for inebilizumab-cdon Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for inebilizumab-cdon Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Inebilizumab-cdon (UPLIZNA)

Introduction

Inebilizumab-cdon, marketed as UPLIZNA, is a biologic drug that has made significant strides in the treatment of various autoimmune diseases. Developed by Viela Bio and now part of Amgen's portfolio, this drug has shown promising results in clinical trials and has started to make a notable impact on the pharmaceutical market.

Mechanism of Action and Clinical Efficacy

UPLIZNA is a CD19-directed cytolytic antibody that targets and depletes B-cells, which are implicated in several autoimmune diseases. It has been approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-AQP4 antibody positive. Clinical trials, such as Study MEDI-551-1155, have demonstrated a significant reduction in the relative risk of relapse by 77% compared to placebo, along with reductions in new central nervous system lesions and annual hospitalization rates[1].

Expanding Indications

Beyond NMOSD, UPLIZNA is being evaluated for other autoimmune conditions. Recent Phase 3 trials have shown positive results for the treatment of Immunoglobulin G4-related disease (IgG4-RD), with an 87% reduction in the risk of IgG4-RD flares compared to placebo[3]. Additionally, the drug is being investigated for generalized myasthenia gravis (gMG), with promising data presented from the Phase 3 MINT trial[4].

Market Performance

UPLIZNA has contributed significantly to Amgen's financial performance. In the third quarter of 2024, UPLIZNA generated $106 million in sales, highlighting its growing market presence. This is part of Amgen's broader success, with total revenues increasing by 23% to $8.5 billion during the same period[2].

Sales Growth and Revenue Contribution

The sales of UPLIZNA are part of Amgen's robust growth in rare disease products, which collectively generated $1.2 billion in sales during the third quarter of 2024. This segment has seen strong volume growth, driven by several first-in-class and early-in-lifecycle medicines, including UPLIZNA[2].

Financial Metrics and Guidance

Amgen's overall financial performance has been strong, with GAAP EPS increasing by 62% to $5.22 and non-GAAP EPS increasing by 13% to $5.58 in the third quarter of 2024. The company has raised its full-year 2024 guidance, reflecting the momentum across its product portfolio, including UPLIZNA[2].

Competitive Landscape

UPLIZNA operates in a competitive landscape dominated by other biologic and immunomodulatory therapies. However, its unique mechanism of action and strong clinical efficacy data position it favorably. The drug's performance is also influenced by broader market factors, including pricing pressure, reimbursement policies, and competition from biosimilars[4].

Pipeline Momentum and Future Growth

Amgen's investment in research and development, including the advancement of UPLIZNA, suggests strong future growth potential. The company's pipeline is diverse, with multiple Phase 3 trials ongoing across various therapeutic areas, including oncology, general medicine, and rare diseases. This pipeline momentum is expected to drive continued innovation and market expansion[2].

Safety and Regulatory Considerations

While UPLIZNA has been generally well-tolerated, it does come with risks associated with B-cell depletion, such as higher rates of infections and declining serum immunoglobulin levels. Regulatory bodies have mandated postmarketing studies to monitor these risks, including a pregnancy observation trial due to potential effects on the immune system of offspring[1].

Quotes from Industry Experts

Robert A. Bradway, Chairman and CEO of Amgen, highlighted the company's strong growth and pipeline momentum: "Strong growth in sales and earnings this quarter reflects the momentum we're building throughout our business. We continue to invest heavily in our rapidly advancing pipeline, with a focus on delivering innovative therapies across our core therapeutic areas"[2].

Illustrative Statistics

• Sales Growth: UPLIZNA generated $106 million in sales in the third quarter of 2024[2].
• Clinical Efficacy: Reduced the relative risk of NMOSD relapse by 77% compared to placebo[1].
• Market Expansion: Part of Amgen's rare disease products that generated $1.2 billion in sales in Q3 2024[2].
• Financial Performance: Amgen's total revenues increased by 23% to $8.5 billion in Q3 2024[2].

Key Takeaways

• UPLIZNA has demonstrated significant clinical efficacy in treating NMOSD and other autoimmune diseases.
• The drug has contributed to Amgen's strong financial performance, particularly in the rare disease segment.
• Ongoing clinical trials and pipeline momentum suggest continued growth and market expansion.
• Regulatory and safety considerations are being closely monitored through postmarketing studies.

FAQs

What is UPLIZNA used for?

UPLIZNA (inebilizumab-cdon) is primarily used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-AQP4 antibody positive. It is also being evaluated for other autoimmune conditions such as Immunoglobulin G4-related disease (IgG4-RD) and generalized myasthenia gravis (gMG)[1][3][4].

How does UPLIZNA work?

UPLIZNA targets and depletes B-cells by binding to CD19, a protein expressed on the surface of B-cells. This leads to the depletion of B-cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP)[1].

What are the potential side effects of UPLIZNA?

Common side effects include infections and declining serum immunoglobulin levels due to B-cell depletion. There is also a potential risk of hypogammaglobulinemia and effects on the immune system of offspring, which are being monitored through postmarketing studies[1].

How has UPLIZNA performed financially?

In the third quarter of 2024, UPLIZNA generated $106 million in sales, contributing to Amgen's overall revenue growth. The drug is part of Amgen's successful rare disease product segment, which generated $1.2 billion in sales during the same period[2].

What is the future outlook for UPLIZNA?

Given its strong clinical efficacy and ongoing evaluations for additional indications, UPLIZNA is expected to continue contributing to Amgen's growth. The company's robust pipeline and investment in research and development further support the potential for future market expansion[2][3][4].

Sources

1. FDA Summary Review: "761142Orig1s000 SUMMARY REVIEW" - FDA.
2. Amgen Financial Results: "AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS" - Stock Titan.
3. Phase 3 Trial Results: "AMGEN ANNOUNCES POSITIVE RESULTS FOR PHASE 3 REGISTRATIONAL TRIAL EVALUATING UPLIZNA (INEBILIZUMAB-CDON) FOR TREATMENT OF IMMUNOGLOBULIN G4-RELATED DISEASE (IgG4-RD)" - PR Newswire.
4. Generalized Myasthenia Gravis Trial: "AMGEN PRESENTS POSITIVE PHASE 3 DATA FOR UPLIZNA (INEBILIZUMAB-CDON) IN GENERALIZED MYASTHENIA GRAVIS (GMG) AT AANEM 2024" - Amgen Newsroom.
5. Amgen Shareholders Report: "SHAREHOLDERS 2023" - Amgen Investors.