In a significant stride for medical science and the millions of Americans affected by Alzheimer’s disease, Eli Lilly & Co. has received FDA approval for its new drug, Kisunla. This approval marks Kisunla as the second drug capable of slowing the progression of this debilitating condition, offering new hope to patients and their families.
A Major Milestone for Eli Lilly and Investors
Eli Lilly & Co. has been eagerly anticipating this moment since Kisunla first demonstrated promising results in clinical trials over three years ago. The journey to approval has been fraught with regulatory hurdles, but the perseverance has paid off. Kisunla will now enter the market to compete with Eisai Co.’s Leqembi, which has been available in the US since early 2023.
On the stock market, shares of Indianapolis-based Lilly experienced a slight dip, closing down 0.8% on Tuesday in New York. Despite this, the company’s stock has surged by over 50% this year, driven by rapid growth in its weight-loss and diabetes segments. In contrast, shares of Eisai’s partner, Biogen Inc., fell by 1.3%.
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Cost and Treatment Dynamics
Lilly has announced that Kisunla will cost $32,000 for the first year of treatment, a price slightly higher than Leqembi’s annual cost of $26,500 for an average-sized individual. However, there is a potential for reduced long-term costs with Kisunla. The drug is designed to halt treatment if brain plaques, the toxic substances it targets, are reduced to minimal levels, which occurred in many trial participants within about a year.
This approach could lead to overall lower out-of-pocket expenses compared to other amyloid-lowering treatments. In contrast, Leqembi’s main approval trial involved an 18-month treatment period.
Efficacy and Side Effects
Both Kisunla and Leqembi work by removing toxic amyloid from the brains of Alzheimer’s patients, offering modest slowing of the disease’s progression. These drugs are specifically approved for individuals with early-stage Alzheimer’s, representing a minority of the patient population. Common side effects include brain swelling and bleeding, which occurred in 36% of patients in Kisunla’s main study, with symptoms manifesting in 6% of these cases. Regular monitoring through scans is essential to manage these risks.
Kisunla offers a potential convenience advantage with its infusion schedule of every four weeks, compared to Leqembi’s bi-weekly regimen. This less frequent dosing could significantly impact patient compliance and quality of life, according to Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation.
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Overcoming Regulatory Challenges
The road to Kisunla’s approval has been marked by a series of delays. Early in 2023, the FDA declined to grant accelerated approval based on initial trial results, opting to wait for data from late-stage trials. Even after these data were submitted, further review time was required. Earlier this year, the FDA convened a day-long hearing to assess Kisunla’s safety and efficacy, ultimately leading to a unanimous vote in favor of the drug on June 10.
Anne White, president of Lilly Neuroscience, expressed the emotional significance of this achievement, highlighting the personal stakes involved in their work. “We have portraits up on our walls of family members to remind us why we’re doing what we’re doing,” she said.
Future Prospects for Alzheimer’s and GLP-1 Drugs
While Alzheimer’s treatments have been a significant focus for Eli Lilly, the company’s GLP-1 medicines for weight loss are projected to drive substantial growth, potentially reaching a $130 billion market by the end of the decade. However, Alzheimer’s drugs are also expected to see significant sales growth, with Bloomberg Intelligence analysts predicting a surge from $250 million this year to $13 billion by 2030.
Joanne Pike, CEO of the Alzheimer’s Association, emphasized the importance of having multiple treatment options. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease,” she stated.
Challenges Ahead for Leqembi
Eisai and Biogen’s rollout of Leqembi has faced several obstacles, including logistical issues, reimbursement uncertainties, and stringent safety testing requirements. Until recently, Medicare did not routinely cover these treatments, and many hospital neurology programs were not equipped to handle the necessary monitoring.
As Kisunla enters the market, the landscape of Alzheimer’s treatment is set to evolve, offering new hope and options for those affected by this challenging disease.
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