Eli Lilly & Co.’s Alzheimer’s treatment has been approved in the U.S., becoming the second drug to slow the progression of the mental-depriving disease that affects 6 million Americans.
It’s a big win for Eli Lilly and its investors, who have been eagerly anticipating the drug since it showed promise in clinical trials more than three years ago. The drug, called Kisunla, experienced multiple regulatory delays during its approval process. It will compete with Eisai Co.’s Leqembi and be available in the United States from early 2023.
Shares of Indianapolis-based Eli Lilly closed down 0.8% in New York on Tuesday. The stock has soared more than 50% year to date on rapid growth in weight loss and diabetes product sales. Eisai partner Biogen Inc. shares fell 1.3%
Eli Lilly says the Alzheimer’s drug will cost $32,000 in the first year of treatment. That’s slightly more than the Leqembi’s annual price of $26,500 for an average-sized person. But if the brain plaque (the toxic substance removed by the drug) dropped to minimal levels, doctors could stop the treatment, which they tested on a number of people after about a year.
Reduce costs
Eli Lilly said this means the drug’s total out-of-pocket costs may sometimes be lower than other amyloid drugs. In Leqembi’s primary approval trial, patients were treated for a full 18 months.
Eisai and Eli Lilly’s products are infusions that remove toxic amyloid from the brains of Alzheimer’s patients. They slow the disease only modestly and are only approved for use in patients with early-stage Alzheimer’s, a small percentage of those with the disease. Side effects of both include brain swelling and bleeding in the brain.
According to the company’s main study, 36% of patients who took Eli Lilly’s drug experienced brain swelling or bleeding, and 6% of them developed symptoms, according to the drug’s label. Regular scans are required to monitor these effects. Eli Lilly’s drug has a potential convenience advantage because it is injected every four weeks, compared with Leqembi’s every two weeks.
Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation, said in an interview before the approval that reducing the frequency of dosing and the possibility of discontinuing treatment “is really a big deal.”
a series of delays
Lilly has encountered a series of delays in bringing Kisunla to market. In early 2023, the FDA declined to give the drug accelerated approval based on early-stage trial results and told the company it wanted to wait for later-stage trials. When Eli Lilly submitted that data, the FDA needed more time to review it. Earlier this year, the agency decided to hold a one-day hearing late in the review process to review the drug’s safety and effectiveness.
An outside advisory panel to the FDA voted unanimously on June 10 to support the drug.
“There was a lot of emotion in the hallway today,” Eli Lilly Neuroscience President Anne White said in an interview before the approval. “We have portraits of family members on our walls to remind us why we do what we do.”
Alzheimer’s disease, once considered integral to Eli Lilly’s future, is now overshadowed by the company’s GLP-1 weight-loss drugs, a market that is expected to reach $100 per year by the end of the decade, according to Goldman Sachs analysts $130 billion.
Sales of Alzheimer’s drugs are also expected to grow significantly. Bloomberg Intelligence analysts expect sales to surge to $13 billion by 2030 from about $250 million this year.
Joanne Pike, chief executive of the Alzheimer’s Society, said in a statement: “Having multiple treatment options is the advancement we have been waiting for – all of us have been affected by this difficult and devastating disease. The nonprofit has been pushing for the approval of amyloid-lowering drugs and broad insurance coverage.
Eisai and its partner Biogen Inc.’s rollout of Leqembi has been slowed by logistical issues, reimbursement uncertainty and complex safety testing requirements. Until recently, Medicare for the Elderly did not regularly cover these treatments, and hospital neurology programs were not set up to perform the monitoring required to use these drugs.
