AVACINCAPTAD PEGOL SODIUM - Generic Drug Details

What are the generic drug sources for avacincaptad pegol sodium and what is the scope of freedom to operate?

Avacincaptad pegol sodium is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avacincaptad pegol sodium has one hundred and two patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for AVACINCAPTAD PEGOL SODIUM

International Patents:	102
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	AVACINCAPTAD PEGOL SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVACINCAPTAD PEGOL SODIUM

Constraining patent/regulatory exclusivity:

10,947,544

Dosage:

SOLUTION;INTRAVITREAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AVACINCAPTAD PEGOL SODIUM

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for AVACINCAPTAD PEGOL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,579,456			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	8,236,773
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,803,931			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	10,947,544			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,538,211			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	9,617,546			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	12,016,875

International Patents for AVACINCAPTAD PEGOL SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2578683	Agents thérapeutiques à base d'aptamères utiles dans le traitement de troubles liés au complément (Aptamer therapeutics useful in the treatment of complement-related disorders)
Australia	2024200948	Methods for treating or preventing ophthalmological conditions
Canada	3124030	AGENTS THERAPEUTIQUES A BASE D'APTAMERES UTILES DANS LE TRAITEMENT DE TROUBLES LIES AU COMPLEMENT (APTAMER THERAPEUTICS USEFUL IN THE TREATMENT OF COMPLEMENT-RELATED DISORDERS)
Spain	2429442
European Patent Office	1850880	Agents thérapeutiques a base d'aptamères utiles dans le traitement de troubles lies au complément (Aptamer therapeutics useful in the treatment of complement-related disorders)
European Patent Office	3385384	AGENTS THÉRAPEUTIQUES À BASE D'APTAMÈRES UTILES DANS LE TRAITEMENT DE TROUBLES LIÉS AU COMPLÉMENT (APTAMER THERAPEUTICS USEFUL IN THE TREATMENT OF COMPLEMENT-RELATED DISORDERS)
Spain	2808955

AVACINCAPTAD PEGOL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Avacincaptad Pegol Sodium

Introduction

Avacincaptad pegol, marketed under the brand name IZERVAY, is a groundbreaking treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Approved by the FDA on August 4, 2023, this drug represents a significant advancement in the treatment of a condition that has long lacked effective therapies.

Market Need and Demand

GA is a leading cause of severe vision loss worldwide, affecting approximately 1 million people in the United States alone. The global prevalence of AMD, which can progress to GA, is estimated to be around 170 million individuals, with this number expected to rise due to an aging population[2][4].

Regulatory Approval and Clinical Efficacy

Avacincaptad pegol's approval is based on positive results from two phase 3 clinical trials, GATHER1 and GATHER2. These trials demonstrated the drug's efficacy in slowing the rate of change in geographic atrophy area over a 12-month period compared to sham treatments. The drug is administered intravitreally monthly, and its benefit-risk ratio is favorable, despite some ocular adverse events such as conjunctival hemorrhage and choroidal neovascularization (CNV)[1][4].

Market Competition

The market for GA treatments has been relatively unaddressed until the approval of avacincaptad pegol. While anti-VEGF therapies are available for the neovascular form of AMD, there were no approved treatments for GA. This makes IZERVAY a pioneering product in its class. However, it will likely face competition from other emerging treatments, such as pegcetacoplan, which is also being evaluated for GA[2][5].

Cost Effectiveness Analysis

A cost-effectiveness analysis of avacincaptad pegol compared to pegcetacoplan has shown varied results. The study indicated that treating GA with avacincaptad pegol every other month (EOM) was more cost-effective than monthly (EM) treatment. However, when assessing extrafoveal lesions, avacincaptad pegol was less cost-effective than pegcetacoplan for both EM and EOM treatment regimens. The costs to treat GA with avacincaptad pegol over two years were estimated at $67,400 for EM and $40,600 for EOM, highlighting the financial implications of treatment frequency[3].

Pricing and Reimbursement

The pricing of avacincaptad pegol will be a critical factor in its market dynamics. Given the high costs associated with the treatment, reimbursement strategies will be essential. The study using 2022 Medicare reimbursement data suggests that the daily cost of delaying GA progression with avacincaptad pegol could be significant, emphasizing the need for comprehensive reimbursement plans to make the treatment accessible to patients[3].

Financial Projections

The financial trajectory of avacincaptad pegol is expected to be robust due to its unique position in the market and the high demand for effective GA treatments. With no prior approved treatments for GA, IZERVAY is poised to capture a significant market share. However, the cost-effectiveness analysis and competition from other emerging treatments will influence its long-term financial performance.

Patient Access and Quality of Life

The approval of avacincaptad pegol marks a significant improvement in the quality of life for patients with GA. By slowing the progression of geographic atrophy, the drug offers hope for preserving vision and reducing the profound decrease in quality of life associated with this condition. Patient access programs and support will be crucial in ensuring that this treatment reaches those who need it most[2][4].

Clinical and Economic Outcomes

Clinical trials have demonstrated that avacincaptad pegol can slow the rate of GA progression, which translates into economic benefits by reducing the need for more intensive and costly interventions later in the disease process. The economic outcomes, including the cost per unit area of retinal pigment epithelium saved, highlight the drug's potential to provide long-term economic benefits despite its high upfront costs[3].

Adverse Events and Safety Profile

While avacincaptad pegol has a favorable benefit-risk ratio, it is associated with certain ocular adverse events, such as conjunctival hemorrhage and CNV. These events, although treatable, will need to be closely monitored and managed to ensure patient safety and maintain trust in the treatment[1][4].

Future Research and Development

Continued research and development will be essential to optimize the use of avacincaptad pegol. Studies on combination therapies, such as coadministration with anti-VEGF agents, and long-term safety and efficacy will further solidify its position in the market[1][5].

Market Penetration and Adoption

The adoption of avacincaptad pegol by healthcare providers and patients will depend on several factors, including clinical evidence, cost-effectiveness, and reimbursement policies. Educational programs and marketing strategies will play a crucial role in promoting the drug and ensuring its widespread adoption.

Global Market Potential

Given the global prevalence of AMD and GA, the market potential for avacincaptad pegol extends beyond the United States. Regulatory approvals in other countries and regions will be necessary to fully realize its global market potential.

Key Takeaways

• Unique Market Position: Avacincaptad pegol is the first approved treatment for geographic atrophy secondary to AMD.
• Clinical Efficacy: Demonstrated superiority in slowing GA progression in clinical trials.
• Cost Effectiveness: More cost-effective with EOM treatment, but less cost-effective than pegcetacoplan for extrafoveal lesions.
• Financial Projections: Robust due to high demand and unique market position.
• Patient Access: Critical for ensuring the treatment reaches those in need.
• Safety Profile: Associated with ocular adverse events, but overall favorable benefit-risk ratio.

FAQs

What is avacincaptad pegol used for?

Avacincaptad pegol, marketed as IZERVAY, is used for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

How is avacincaptad pegol administered?

It is administered intravitreally, typically once a month, at a concentration of 20 mg/mL.

What are the common adverse events associated with avacincaptad pegol?

Common adverse events include conjunctival hemorrhage and choroidal neovascularization (CNV).

Is avacincaptad pegol cost-effective?

The cost-effectiveness varies depending on the treatment frequency and comparison with other treatments. It is more cost-effective with every other month (EOM) treatment but less cost-effective than pegcetacoplan for extrafoveal lesions.

What is the global market potential for avacincaptad pegol?

Given the global prevalence of AMD and GA, the market potential for avacincaptad pegol is significant and extends beyond the United States, pending regulatory approvals in other countries.

Sources

1. FDA Clinical Review: "217225Orig1s000 CLINICAL REVIEW(S) - Avacincaptad Pegol"
2. DrugBank: "Avacincaptad pegol sodium"
3. PubMed: "A Cost Effectiveness Analysis of Avacincaptad Pegol for Geographic Atrophy"
4. FDA Summary Review: "217225Orig1s000 SUMMARY REVIEW - Avacincaptad Pegol"
5. Ophthalmology Retina: "A Cost-Effectiveness Analysis of Pegcetacoplan for the Treatment of Geographic Atrophy"