Introduction
In the tough terrain of finding an Alzheimer’s cure, Eli Lilly is setting the pace with their latest innovation – the FDA-approved drug, Donanemab, commercially known as Kisunla. This blog delves into Lilly’s strategic maneuvers to expedite sales and cultivate urgent demand within the pharmaceutical sector. The vast population of patients combined with a significant unfulfilled requirement presents a market begging for a breakthrough. However, preliminary drugs have not lived up to expectations in terms of sales. Continue reading to discover Lilly’s ambitious plans to overturn this scenario and its potential impact on the future of Alzheimer’s treatment.
A New Dawn with Donanemab
Eli Lilly’s approval of Donanemab in July marks a significant milestone in Alzheimer’s treatment. Unlike previous attempts, Lilly is determined to create a sense of urgency around Kisunla. This isn’t just another drug launch; it’s a rallying cry for transforming the Alzheimer’s market landscape.
In an 18-month clinical study, participants who received Kisunla experienced a notable decrease in amyloid plaques compared to those who were given a placebo. On average, Kisunla reduced amyloid plaques by 61% at 6 months, 80% at 12 months, and 84% at 18 months from the beginning of the study.
The drug aims to tackle the disease head-on by focusing initially on dementia specialists and neurologists within advanced healthcare systems. This targeted approach ensures that the medical professionals most equipped to handle these novel treatments are the first to adopt and advocate them.
Lilly’s Vice President of Alzheimer’s Disease Marketing, Andrew Lechleiter, acknowledges the challenges. The company is entering a space filled with denial and complacency and must drive a sense of urgency in the marketplace. Their strategy is clear, but will the market respond?
Tackling Complacency and Denial
In an industry often plagued by slow adoption and skepticism, Lilly is determined to combat the misconception that memory issues are merely part of aging. This complacency has been a significant barrier to the widespread adoption of Alzheimer’s treatments.
Lilly plans to roll out a marketing blitz aimed at raising awareness among primary care physicians. These physicians often serve as the first point of contact for patients experiencing memory issues, making them crucial in early diagnosis and treatment initiation.
Adding a layer of credibility and visibility, Lilly is aligning with Paralympic athlete Nick Mayhugh as a brand ambassador. Using the Olympics as a platform, they aim to reach a broader audience and emphasize the importance of early intervention and treatment.
Drug Pipelines
There are currently eight drugs approved for treating Alzheimer’s disease. Among these, two (Aducanumab and Lecanemab) address the underlying biology of the condition and can slow cognitive and functional decline in certain patients. Five of the remaining drugs (Donepezil, Rivastigmine, Galantamine, Memantine and Memantine combined with Donepezil) are aimed at alleviating the symptoms of Alzheimer’s dementia. Brexpiprazole, another one of the FDA-approved drugs, is specifically used to manage agitation that may occur in patients.
Eli Lilly is also conducting clinical trials for Remternetug, a successor to Donanemab. In August 2022, Lilly launched a Phase 3 trial known as TRAILRUNNER-ALZ1. This study was initially set to randomize 600 individuals with early symptomatic Alzheimer’s disease to receive either the antibody or a placebo for one year, administered through intravenous infusion or subcutaneous injection. The main goal is to measure the percentage of patients who have their amyloid plaques cleared by the end of the treatment period. The trial will take place at 75 sites in the U.S. and two in Japan, with completion expected by September 2026.
On May 7, 2024, the Dominantly Inherited Alzheimer Network announced that Remternetug would be included in the Knight Family DIAN-TU Primary Prevention Trial. This trial aims to enroll 220 individuals up to 25 years old who carry familial Alzheimer’s disease mutations but have little to no brain amyloid. Participants will receive either Remternetug or a placebo over a period of four years, with the primary outcome being the accumulation of amyloid.
Focusing on High-Impact Areas
Lilly is strategically targeting regions with senior populations and enhanced access to diagnostic tools. This focus ensures that the areas most affected by Alzheimer’s receive the attention and resources needed to drive effective treatment.
Despite over six million people in the U.S. living with Alzheimer’s, Lilly estimates that only about 1.3 million are suitable for current treatments. This gap highlights the urgent need for improved diagnostic and treatment pathways.
Investment analysts like Evan Seigerman view this year as foundational. Building the necessary infrastructure is crucial for the future success of Alzheimer’s treatments, and Lilly’s current efforts are a step in the right direction.
Building a Community of Awareness
Creating a sense of urgency within the Alzheimer’s market extends beyond healthcare professionals. Engaging patients, caregivers, and the broader community is equally important.
Lilly’s marketing efforts aim to foster a community that understands the importance of early diagnosis and treatment. By raising awareness and providing valuable information, they hope to empower individuals to seek help sooner rather than later.
Overcoming Market Obstacles
The Alzheimer’s market is fraught with challenges, primarily due to the lack of preparedness. Geriatrician Nathaniel Chin draws a stark contrast with the cancer market, which benefits from a well-established network of precision treatments, therapy layers, and diagnostic guidance.
Initial approaches to prescribing these drugs have leaned towards caution, emphasizing shared decision-making over individual prescriptions. However, Lilly is optimistic that this restrictive approach will shift over time as the medical community becomes more familiar with Kisunla.
A commercial launch, coupled with patient inquiries and the appealing once-a-month dosing regimen of Donanemab, could signal a promising shift in the market’s approach to Alzheimer’s treatment.
The Role of PET Imaging
One of the critical hurdles in Alzheimer’s treatment adoption is the high cost and limited availability of PET imaging agents. These agents are essential for accurately diagnosing Alzheimer’s and determining eligibility for treatments like Donanemab.
Lilly remains hopeful that policy changes to incentivize PET imaging agents will significantly enhance accessibility. Such changes could make it easier for patients to receive accurate diagnoses and timely treatment, ultimately improving outcomes.
The Skepticism Surrounding Shorter Dosing Claims
While Donanemab‘s once-a-month dosing regimen is appealing, skepticism remains. Critics question the practicality of Lilly’s shorter dosing claims, and whether this will truly drive treatment adoption.
Lilly remains confident that the convenience of monthly dosing, coupled with its targeted marketing efforts and community engagement initiatives, will ultimately drive success for Donanemab in the Alzheimer’s market.
Conclusion
In conclusion, Lilly is taking a strategic approach to launching Kisunla and creating a sense of urgency within the Alzheimer’s market. Their efforts to combat complacency and denial, focus on high-impact areas, address market obstacles, and engage patients and communities demonstrate their dedication to improving outcomes for those living with this devastating disease. The future may hold even more promise as advancements in PET imaging accessibility and policy changes could further enhance treatment options for Alzheimer’s patients.
Image by ximagination /www.123rf.com.