\n
![](\"https:\/\/fortune.com\/img-assets\/wp-content\/uploads\/2024\/07\/GettyImages-2092481340-e1719957327721.jpg?w=2048\")
<\/p>\n [ad_1]
\n<\/p>\n
Eli Lilly<\/a> & Co.\u2019s Alzheimer\u2019s treatment was cleared in the US as the second drug to slow progression of the mind-robbing disease that afflicts 6 million Americans.<\/p>\n It\u2019s a big win for Lilly and its investors, who have been eagerly anticipating the drug since it\u00a0showed promise<\/a>\u00a0in clinical trials more than three years ago. Called Kisunla, the medicine endured a number of regulatory delays on the road to approval. It will compete with Eisai Co.\u2019s Leqembi, which has been\u00a0available for sale<\/a>\u00a0in the US since early 2023.<\/p>\n Shares of Indianapolis-based Lilly closed down 0.8% Tuesday in New York. The stock had surged more than 50% so far this year before today amid rapid growth of weight-loss and diabetes sales. Shares of Eisai partner Biogen<\/a> Inc. fell 1.3%<\/p>\n The Alzheimer\u2019s drug will cost $32,000 in the first year of treatment, Lilly said. That\u2019s slightly more than the $26,500 annual price for Leqembi for a person of average size. But doctors can stop the treatment if brain plaques \u2014 the toxic material that the drug removes \u2014 fall to minimal levels, which they did in many people in trials after about a year.<\/p>\n That means that the total out-of-pocket treatment cost of the drug could sometimes be less than other amyloid drugs, Lilly said. In Leqembi\u2019s main approval trial, patients were treated for a full 18 months. Brain swelling or bleeding occurred in 36% of patients on Lilly\u2019s drug in the company\u2019s main study, and produced symptoms in 6% of them, according to the drug\u2019s label. Regular scans are required to monitor for these effects. Lilly\u2019s drug has a potential convenience advantage since it\u2019s infused every four weeks, compared with every two for Leqembi. Lilly faced a series of delays bringing Kisunla to the market. In early 2023, the FDA\u00a0refused<\/a>\u00a0to give the drug accelerated approval based on early trial results, telling the company it wanted to wait for a late-stage trial. When Lilly submitted that data, the FDA needed more time to review it. Then earlier this year, the agency decided late in the review process to convene a day-long hearing to review the drug\u2019s safety and efficacy.<\/p>\n A panel of outside advisers to the FDA\u00a0voted unanimously<\/a>\u00a0in favor of the drug on June 10. Once considered integral to Lilly\u2019s future, Alzheimer\u2019s has been overshadowed by the company\u2019s GLP-1 medicines that aid in weight loss, a market expected to\u00a0reach $130 billion<\/a>\u00a0a year by the end of the decade, according to analysts at Goldman Sachs<\/a>.<\/p>\n Sales of Alzheimer\u2019s drugs are also expected to grow significantly. Bloomberg Intelligence analysts see sales surging to $13 billion by 2030 from about $250 million this year.<\/p>\n \u201cHaving multiple treatment options is the kind of advancement we\u2019ve all been waiting for \u2014 all of us who have been touched, even blindsided, by this difficult and devastating disease,\u201d said Joanne Pike, CEO of the Alzheimer\u2019s Association, in a statement. The nonprofit has pushed hard for approval and broad insurance coverage for amyloid-lowering drugs.<\/p>\n Leqembi\u2019s rollout by Eisai and partner Biogen Inc. has been slowed by logistical issues,\u00a0reimbursement uncertainties<\/a>\u00a0and complicated safety testing requirements. Medicare, the US health program for the elderly, didn\u2019t routinely cover the treatments until recently, and hospital neurology programs weren\u2019t set up to perform the monitoring required to use the drugs.<\/p>\n<\/div>\n\nLower cos<\/strong>ts<\/h2>\n
The Eisai and Lilly products are both infusions that remove toxic amyloid from the brains of Alzheimer\u2019s patients. They only modestly slow the disease and are approved only for people with early-stage Alzheimer\u2019s, a\u00a0minority<\/a>\u00a0of the total patient population with the disease. Side effects of both include brain swelling and brain bleeding.<\/p>\n
Less frequent dosing and the potential to stop treatment are \u201ca really big deal,\u201d\u00a0Howard Fillit<\/a>, co-founder of the Alzheimer\u2019s Drug Discovery<\/a> Foundation, said in an interview before the approval.<\/p>\nSeries of delays<\/strong><\/h2>\n
\u201cThere\u2019s a lot of emotion in the hallways today,\u201d\u00a0Anne White<\/a>, president of Lilly Neuroscience, said in an interview before the approval. \u201cWe have portraits up on our walls of family members to remind us why we\u2019re doing what we\u2019re doing.\u201d<\/p>\nSubscribe to the Fortune Next to Lead newsletter to get weekly strategies on how to make it to the corner office. Sign up for free<\/a>.<\/div>\n