The FDA approved a new Alzheimer’s drug, Kisunla, from Eli Lilly, following unanimous recommendation by an expert panel. Kisunla, which targets the amyloid protein linked to Alzheimer’s, is the third such drug on the market, after Eisai and Biogen’s Leqembi. It is prescribed for patients with mild cognitive impairment or dementia due to Alzheimer’s, with confirmed amyloid pathology. Kisunla’s label includes a safety warning for ARIA, an imaging abnormality associated with brain bleeding and swelling. The drug is priced at $32,000 annually but may be cheaper for patients whose amyloid levels decrease quickly. Unlike its predecessors, Kisunla received traditional FDA approval, enabling Medicare reimbursement.

Alzheimer’s cases are projected to increase significantly, emphasizing the need for early disease detection. The economic impact is substantial, with costs potentially reaching $1 trillion by 2050.

A New Hope for Alzheimer’s Treatment

Kisunla’s Mechanism and Target Population

Kisunla is the third drug of its kind to reach the market, following similar treatments from Eisai and Biogen. The FDA has approved Kisunla for use in a patient population similar to that of Eisai and Biogen’s Leqembi. The drug is intended for patients with mild cognitive impairment or dementia due to Alzheimer’s, provided they have confirmed amyloid pathology.

Addressing Safety Concerns

The FDA’s approval comes with a safety warning for the risk of an imaging abnormality called ARIA, which is usually asymptomatic but can be associated with serious brain bleeding and swelling. The label for Kisunla also advises doctors to test for a genetic profile linked to higher rates of ARIA, similar to the warning for Leqembi.

Pricing and Economic Impact

Cost of Treatment

Eli Lilly has priced Kisunla at just under $700 per vial, amounting to approximately $32,000 annually if a patient continues treatment for one year. This is higher than the $26,500 annual cost for Leqembi. However, Lilly’s trials for Kisunla included a dosing strategy where treatment could be stopped if the drug successfully cleared amyloid from the brain, potentially making it less expensive for some patients.

Potential for Reduced Costs

Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, expressed optimism about the potential for treatment cessation, which could reduce out-of-pocket costs and the burden of infusion for eligible patients.

FDA Approval and Medicare Coverage

Traditional Approval Pathway

Unlike Biogen’s Aduhelm and Eisai’s Leqembi, which initially received accelerated approvals, Kisunla received traditional FDA approval. This pathway requires more comprehensive data and may lead to broader acceptance and reimbursement. Lilly initially sought accelerated approval but was asked to provide additional data on trial participants who had been exposed to more than one year of treatment.

Medicare Reimbursement

With full FDA approval, Kisunla is expected to be reimbursed under the federal Medicare program, which covers most people with Alzheimer’s disease. This is a significant development, as neither Aduhelm nor Leqembi were eligible for Medicare coverage under their initial accelerated approvals.

Research and Market Dynamics

The Amyloid Hypothesis

The development of Kisunla is the result of many years of research focusing on the amyloid hypothesis, which posits that amyloid plaques impair brain cell communication. Despite previous drugs targeting amyloid failing to provide a benefit, Kisunla, along with Leqembi, represents a new wave of treatments offering hope for patients and caregivers.

Commercial Expectations

Analysts have debated the commercial prospects of Kisunla compared to Leqembi. While data suggest Leqembi may be safer, Kisunla offers convenience with its four-week dosing schedule compared to Leqembi’s biweekly administration. Despite the lack of direct comparison, Kisunla is expected to become a blockbuster drug for Eli Lilly, potentially generating close to $5 billion in annual sales at its peak.

The Growing Challenge of Alzheimer’s

Increasing Prevalence

The approval of Kisunla comes at a critical time as the prevalence of Alzheimer’s disease is projected to increase significantly. Nearly 7 million Americans currently live with Alzheimer’s, and this number is expected to rise to nearly 13 million by 2050. Globally, 153 million people are projected to have Alzheimer’s by 2050, tripling current numbers.

Public Health and Economic Impact

The rapid growth in Alzheimer’s cases is driven by an aging population, particularly those aged 65 and older, who are at the highest risk. By 2060, about 13.8 million Americans in this age group are expected to have Alzheimer’s dementia. The economic impact is also substantial, with health and long-term care costs for people with dementia projected to reach $360 billion in 2024 and nearly $1 trillion by 2050.

Insights

1. Kisunla targets amyloid protein, crucial in Alzheimer’s treatment.
2. Safety concerns include ARIA, requiring genetic testing.
3. Traditional FDA approval allows Medicare reimbursement.
4. Alzheimer’s cases and economic costs are projected to rise significantly.

The Essence (80/20)The Origins and Evolution of the 80/20 Principle The Discovery by Vilfredo Pareto In 1897, Italian economist Vilfredo Pareto uncovered a striking pattern in his study of wealth and... More

The core topic is the FDA approval of Kisunla, a new Alzheimer’s drug by Eli Lilly, which targets amyloid proteins in the brain. Key points include its traditional FDA approval, safety warnings for ARIA, and potential cost benefits due to a unique dosing strategy. The approval reflects the ongoing need for effective Alzheimer’s treatments amid rising cases and substantial economic impact.

The Action Plan – What the Healthcare Industry Will Do

1. Monitor Patients: Start treatment in patients with mild cognitive impairment or dementia due to Alzheimer’s, confirmed by amyloid pathology.
2. Safety Protocols: Implement genetic testing to assess ARIA risk and regularly monitor patients for imaging abnormalities.
3. Cost Management: Adopt the dosing strategy recommended by the FDA to potentially reduce treatment costs.
4. Awareness and Education: Increase awareness about early detection and treatment options for Alzheimer’s to manage the projected rise in cases effectively.

Blind Spots

The focus on amyloid proteins as the primary target may overlook other potential contributing factors to Alzheimer’s disease, necessitating broader research into alternative pathways and treatments.

Another potential blind spot is the limited effectiveness of amyloid-targeting drugs in diverse populations. Clinical trials often have restrictive enrollment criteria, which might not reflect the full spectrum of patients with Alzheimer’s. This includes variations in genetic backgrounds, comorbid conditions, and socio-economic factors that can influence the disease’s progression and treatment outcomes. This oversight could limit the real-world applicability and benefits of the drug, underscoring the need for more inclusive research and personalized treatment approaches.

LLY Technical Analysis

Price Trend: The stock price has been in an uptrend for the majority of the period shown. It reached a high of $911.48 and currently sits at $908.15. The 50-day moving average (blue line) is at $827.18, indicating a short-term uptrend, while the 200-day moving average (red line) is at $701.81, suggesting a long-term uptrend as well.

Volume: The volume bars show periods of high trading activity, particularly noticeable in recent days. This could indicate strong interest or significant moves in the stock.

Relative Strength IndexIn the world of technical analysis, the Relative Strength Index (RSI) stands as a cornerstone tool for traders seeking insights into market momentum. Developed by J. Welles Wilder ... More (RSI): The RSI is at 72.39, which is above the overbought threshold of 70. This suggests the stock might be overbought and could be due for a pullback.

On-Balance VolumeThe On Balance Volume indicator (OBV) is a technical analysis tool used to measure the flow of money into and out of a security over a specified period of time. It is a cumulative ... More (OBV): The OBV is relatively stable at 199.08M, indicating that the volume flow is not showing strong divergences with the price trend, which supports the ongoing uptrend.

Stochastic RSIIn the realm of technical analysis, the Stochastic RSI (StochRSI) emerges as a powerful tool for traders seeking to navigate market dynamics with precision. Developed by Tushar S. ... More: The Stochastic RSI is at 0.222, which is in the oversold territory. This might suggest a potential buying opportunity if the price reverses upward from here.

Average Directional IndexThe Average Directional Index (ADX) stands as a cornerstone indicator in the toolkit of technical traders, offering insights into the strength of market trends. Developed by Welles... More (ADX): The ADX is at 43.20, indicating a strong trend. Values above 20 typically suggest a strong trend, and above 40 indicates a very strong trend, which supports the upward price movement.

Chaikin OscillatorNamed after its creator Marc Chaikin, the Chaikin Oscillator stands as a formidable tool in the arsenal of technical analysts. This oscillator is designed to measure the accumulati... More: The Chaikin Oscillator is at 1.37M, which is slightly positive. This suggests some accumulation, indicating buying pressure might be present.

Key Points to Note:

• The stock is in a strong uptrend as indicated by the moving averages and ADX.
• RSI indicates potential overbought conditions, suggesting caution for new long positions.
• The Stochastic RSI indicates oversold conditions, which may imply a short-term buying opportunity.
• The stable OBV supports the current price trend without significant divergence.
• Volume spikes should be monitored for any potential trend reversals or continuation.

Time-Frame Signals:

• 3 months: Hold. Given the current uptrend and overbought RSI, it might be prudent to wait for a clearer signal before making new investments.
• 6 months: Buy. Assuming the trend continues and there are no major negative divergences or changes in market conditions, the stock shows potential for continued growth.
• 12 months: Buy. The long-term moving average trend and overall market indicators suggest that the stock could continue its upward trajectory over the next year.

This analysis suggests a cautious approach in the short term due to the overbought RSI, but a positive outlook for the medium to long term based on the strong trend indicators.

Keep in mind that past performance does not indicate future outcomes. It’s essential to do your own research and consider speaking with a financial advisor before making any investment decisions. 🧡

Looking Ahead

The FDA’s approval of Kisunla marks a significant milestone in the fight against Alzheimer’s disease. While challenges remain, including safety concerns and the need for early detection, Kisunla offers new hope for patients and caregivers. As research continues and treatments evolve, the potential to alter the trajectory of Alzheimer’s disease becomes increasingly promising.

Frequently Asked Questions about Kisunla – Alzheimer’s Drug