Lanadelumab-flyo - Biologic Drug Details

Summary for lanadelumab-flyo

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

Pharmacology for lanadelumab-flyo

Mechanism of Action	Kallikrein Inhibitors
Established Pharmacologic Class	Plasma Kallikrein Inhibitor

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 lanadelumab-flyo Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for lanadelumab-flyo Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for lanadelumab-flyo Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Lanadelumab-flyo

Introduction to Lanadelumab-flyo

Lanadelumab-flyo, marketed as TAKHZYRO, is a biologic drug developed by Takeda Pharmaceutical Company Limited. It is indicated for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 2 years and older. This drug belongs to the class of monoclonal antibodies and works by decreasing plasma kallikrein activity to control excess bradykinin generation, thereby preventing HAE attacks[2][4].

Market Size and Growth

The global lanadelumab market is projected to grow at a revenue Compound Annual Growth Rate (CAGR) of 7.6% from 2023 to 2031. This growth is driven by the increasing prevalence of HAE globally and the competitive advantage of lanadelumab in preventing HAE attacks[1].

Regional Market Dynamics

The market is segmented geographically, with North America currently holding the largest market size due to a higher prevalence of HAE in this region. However, the Asia Pacific region is identified as a key growth area, driven by increasing demand in countries such as China, Japan, and India[1].

Market Segmentation by Age Group

The lanadelumab market is also segmented by age group. The adult segment dominates the market, but recent approvals and studies have expanded the use of lanadelumab-flyo to pediatric patients aged 2 to less than 12 years. This expansion is expected to further drive market growth[1][4].

Competitive Landscape

The competitive landscape of the lanadelumab market involves analyzing key competitors, industry trends, and market dynamics. Takeda Pharmaceutical Company Limited is the primary player in this market, and the company continues to invest in research and development to enhance the understanding of HAE, explore new indications, and improve treatment outcomes[1].

Financial Performance and Cost Considerations

Lanadelumab-flyo is a high-cost medication, with an average yearly cost ranging from $533,988 to $266,994, depending on the dosing interval. The cost per vial is approximately $20,538. Despite its high cost, the drug's efficacy in reducing HAE attacks significantly contributes to its market acceptance. However, ongoing monitoring of long-term safety and potential adverse events is crucial to maintain this acceptance[1].

Impact of Pricing Dynamics

The financial trajectory of lanadelumab-flyo can be influenced by pricing dynamics, particularly in the context of exclusivity periods and post-exclusivity price reductions. Studies have shown that price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can significantly impact the cost-effectiveness of biologic treatments. For instance, a 2% yearly price increase followed by a 40% post-exclusivity price reduction can result in varying impacts on the cost-effectiveness ratio[3].

Clinical Efficacy and Safety

Clinical studies, such as the HELP and SPRING studies, have demonstrated the efficacy and safety of lanadelumab-flyo in both adult and pediatric patients. The drug has shown significant reductions in HAE attack rates, with up to 99.5% of days being attack-free in pediatric patients. The pharmacokinetic properties of lanadelumab-flyo are dose-proportional, and the drug has a terminal elimination half-life of approximately two weeks[2][4][5].

Real-World Evidence and Patient Outcomes

Real-world evidence from studies like the EMPOWER study provides insights into the effectiveness of lanadelumab-flyo in reducing HAE attack rates, improving quality of life, and controlling angioedema. These studies support the drug's use in diverse patient populations and reinforce its safety and efficacy profile[4].

Strategic Developments and Market Expansion

Takeda continues to present new data analyses and expand the use of lanadelumab-flyo into new geographies and patient populations. The recent FDA approval for pediatric use and ongoing research into its efficacy in patients with normal C1-inhibitor HAE (nC1-INH-HAE) are key strategic developments that will drive market growth[4].

Challenges and Restricting Factors

Despite the positive market dynamics, the high cost of lanadelumab-flyo and safety concerns related to long-term use are significant restricting factors. Ongoing monitoring and research are essential to address these concerns and maintain market acceptance[1].

Key Takeaways

• Market Growth: The lanadelumab market is expected to grow at a CAGR of 7.6% from 2023 to 2031.
• Regional Dynamics: North America is the largest market, but the Asia Pacific region is a key growth area.
• Age Group Segmentation: The adult segment dominates, but pediatric use is expanding.
• Financial Performance: High cost, but significant efficacy in reducing HAE attacks.
• Clinical Efficacy: Demonstrated safety and efficacy in clinical and real-world studies.
• Strategic Developments: Ongoing research and expansion into new geographies and patient populations.

Frequently Asked Questions (FAQs)

Q1: What is lanadelumab-flyo used for? Lanadelumab-flyo, marketed as TAKHZYRO, is used for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 2 years and older.

Q2: How does lanadelumab-flyo work? Lanadelumab-flyo works by decreasing plasma kallikrein activity to control excess bradykinin generation, thereby preventing HAE attacks.

Q3: What is the expected market growth for lanadelumab-flyo? The global lanadelumab market is projected to grow at a revenue CAGR of 7.6% from 2023 to 2031.

Q4: What are the main challenges facing the lanadelumab-flyo market? The high cost of the medication and safety concerns related to long-term use are significant challenges.

Q5: Who is the primary player in the lanadelumab-flyo market? Takeda Pharmaceutical Company Limited is the primary player in the lanadelumab-flyo market.

Sources:

1. Growth Plus Reports - Lanadelumab Market Forecast 2031 - CAGR of 7.6% | GPR
2. FDA - TAKHZYRO (lanadelumab-flyo) Label
3. PubMed - The Influence of US Drug Price Dynamics on Cost-Effectiveness ...
4. Takeda - Takeda to Present Multiple New Data Analyses at 2023 AAAAI ...
5. TAKHZYRO - Clinical Studies Brochure

Last updated: 2024-12-20