Alzheimer’s Disease – Unmet Need – Detailed, Expanded Analysis: Early Alzheimer’s Disease (US/EU)
Over the past two decades, in response to mounting failures, clinical trials of disease-modifying therapies (DMTs) in Alzheimer’s disease (AD) have moved earlier in the disease spectrum to increase the probability of success; today, most Phase III clinical trials enroll patients with early AD, commonly comprising mild cognitive impairment (MCI) due to AD and mild AD dementia. In June 2021, Biogen / Eisai’s anti-Aβ MAb aducanumab (Aduhelm) received accelerated approval from the FDA for the treatment of early AD, rendering it the first potential DMT approved for this disease. Although the drug’s approval has been met with considerable controversy, it, nevertheless, marks the dawn of a new era in drug development, disease management, and regulatory standards in this indication. Other DMTs (Eisai / Biogen’s lecanemab, Eli Lilly’s donanemab, Roche’s gantenerumab, Novo Nordisk’s semaglutide) may soon follow. As the AD therapy market enters this new era, it is essential to understand how neurologists perceive the performance of current therapies in early AD patients and their expectations for future DMTs on key clinical and nonclinical attributes.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for early AD?
- What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for early AD?
- What are the prevailing areas of unmet need and opportunity in early AD?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European neurologists for a hypothetical DMT for early AD?
PRODUCT DESCRIPTION
Provides quantitative insight into U.S. and European physicians’ perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 31 European neurologists fielded in February 2022
Key companies: Eisai, Johnson & Johnson, Novartis, AbbVie, Lundbeck, Grünenthal, Biogen, Eli Lilly, Roche, Novo Nordisk.
Key drugs: donepezil, galantamine, rivastigmine patch, memantine, Namzaric, Aduhelm, lecanemab, donanemab, gantenerumab, and semaglutide.
Table of contents
- Alzheimer's Disease - Unmet Need - Detailed, Expanded Analysis: Early Alzheimer's Disease (US/EU)
- Executive summary
- Unmet Need - Early AD - Executive Summary - March 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products / regimens for early AD and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed neurologists' prescribing decisions in early AD
- Importance of efficacy attributes to prescribing decisions in early AD: United States
- Importance of efficacy attributes to prescribing decisions in early AD: Europe
- Importance of safety and tolerability attributes to prescribing decisions in early AD: United States
- Importance of safety and tolerability attributes to prescribing decisions in Early AD: Europe
- Importance of convenience of administration attributes to prescribing decisions in early AD: United States
- Importance of convenience of administration attributes to prescribing decisions in early AD: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, and convenience of administration to prescribing decisions in early AD: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, and convenience of administration to prescribing decisions in early AD: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for early AD: United States
- Overall performance of key therapies for early AD: Europe
- Mean overall performance of key therapies for early AD: United States and Europe
- Relative performance of key therapies for early AD across select efficacy attributes: United States
- Relative performance of key therapies for early AD across select efficacy attributes: Europe
- Relative performance of key therapies for early AD across select safety and tolerability attributes: United States
- Relative performance of key therapies for early AD across select safety and tolerability attributes: Europe
- Relative performance of key therapies for early AD across select convenience of administration attributes: United States
- Relative performance of key therapies for early AD across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in early AD
- Surveyed neurologistsu2019 satisfaction with the performance of key therapies for early AD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed neurologists' satisfaction with the performance of key therapies for early AD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed neurologists' ascribed level of unmet need across key efficacy attributes in early AD: United States
- Surveyed neurologists' ascribed level of unmet need across key efficacy attributes in early AD: Europe
- Surveyed neurologists' ascribed level of unmet need across key safety and tolerability attributes in early AD: United States
- Surveyed neurologists' ascribed level of unmet need across key safety and tolerability attributes in early AD: Europe
- Surveyed neurologists' ascribed level of unmet need across key convenience of administration attributes in early AD: United States
- Surveyed neurologists' ascribed level of unmet need across key convenience of administration attributes in early AD: Europe
- Key findings: unmet need in early AD and related indications
- Surveyed neurologists' ascribed level of unmet need in early AD and related indications: United States
- Surveyed neurologists' ascribed level of unmet need in early AD and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the early AD market and emerging therapy insights
- Opportunity: effective DMTs
- Opportunity: DMTs with minimal AEs
- Opportunity: conveniently delivered DMTs
- Opportunity: improved symptomatic treatments
- Areas of opportunity in the early AD market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of a key current therapy for the treatment of early AD
- Attribute importance and part-worth utilities
- Early AD target product profile: attribute importance
- Percent reduction from baseline in CDR-SB scores at 18-24 months vs. placebo (primary end point)
- Percent reduction from baseline in ADAS-cog scores at 18-24 months vs. placebo
- Percent reduction in patients transitioning from MCI to AD at 18-24 months vs. placebo
- Percent of patients with complete Au03b2 plaque clearance at 18-24 months
- Incidence of ARIA-E (% of patients)
- Delivery profile
- List price per year
- Conjoint analysis-based simulation of a market scenario
- Early AD market simulation: share of preference of target product profiles included in the market scenario
- Early AD market simulation: likelihood to prescribe target product profiles included in the market scenario
- Early AD market simulation: target product profiles included in the market scenario
- Appendix
- Bibliography
- Executive summary
Meher Baba Kumar Nakka, M.S.(Pharm.), is an analyst on the CNS/Ophthalmology Disorders team at Clarivate. In this capacity, he works on a range of neurological indications, such as pain and migraine, and neurodegenerative disorders, such as Alzheimer’s disease. He holds a bachelor’s degree in pharmacy from Jawaharlal Nehru Technological University in Hyderabad and a master’s degree in pharmacoinformatics from the National Institute of Pharmaceutical Education and Research in Mohali.