Eli Lilly & Co.’s Alzheimer’s drug has been approved in the United States, becoming the second drug to slow the progression of the mind-robbing disease that affects 6 million Americans.
It’s a big win for Lilly and the company’s investors, who have been eagerly awaiting the drug since it was first announced. has shown promise in clinical trials more than three years ago. Called Kisunla, the drug has suffered several regulatory delays on its way to approval. It will compete with Eisai Co.’s Leqembi, which has available for sale in the United States from early 2023.
Shares of Indianapolis-based Lilly closed down 0.8% in New York on Tuesday. The stock had risen more than 50% so far this year before today amid surging sales of its weight-loss and diabetes drugs. Shares of Eisai Partners Biology Inc. down 1.3%
The Alzheimer’s drug will cost $32,000 for the first year of treatment, Lilly said. That’s slightly higher than Leqembi’s $26,500 annual price for an average-sized person. But doctors can stop treatment if brain plaques—the toxic material the drug clears—reduce to a minimum, which they did in many people in trials after about a year.
Lower Costs
Lilly said that means the total cost of treatment with the drug can sometimes be lower than with other amyloid drugs. In Leqembi’s main approval trial, patients were treated for 18 months.
Eisai and Lilly’s products are both infusions that remove toxic amyloid from the brains of Alzheimer’s patients. They only modestly slow the disease and are approved only for people with early-stage Alzheimer’s, a minority in total patients with the disease. Side effects of both include brain swelling and brain bleeding.
Brain swelling or bleeding occurred in 36 percent of patients taking Lilly’s drug in the company’s main study and caused symptoms in 6 percent of them, according to the drug’s label. Regular scans are needed to monitor for these effects. Lilly’s drug has a potential convenience advantage because it is infused every four weeks, compared with every two weeks for Leqembi.
Less frequent dosing and the possibility of stopping treatment is “a really big issue,” Howard Fillitco-founder of Alzheimer’s drug Discover Platform, said in an interview ahead of the approval.
Chain of Delays
Lilly has faced a series of delays in bringing Kisunla to market. In early 2023, the FDA denied to approve the drug faster based on the results of its initial trial, telling the company that it wanted to wait for a later-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 one-day hearing to review the drug’s safety and effectiveness.
An outside advisory group to the FDA voted unanimously support this drug on June 10.
“There was a lot of emotion in the hallway today,” Anne White“We hang portraits of family members on the wall to remind us why we do what we do,” Lilly Neuroscience president and CEO said in an interview before the approval.
Once seen as an integral part of Lilly’s future, Alzheimer’s has been overshadowed by the company’s weight-loss GLP-1 drugs, a market that was expected to reached 130 billion dollars a year by the end of the decade, according to analysts at Goldman Sachs.
Sales of Alzheimer’s drugs are also expected to increase significantly, with Bloomberg Intelligence analysts predicting sales will soar to $13 billion by 2030 from about $250 million this year.
“Having multiple treatment options is the kind of progress we’ve all been waiting for—all of us who have been affected, even surprised, by this difficult and devastating disease,” said Joanne Pike, CEO of the Alzheimer’s Association, in a statement. The nonprofit has pushed hard for approval and widespread coverage of amyloid-lowering drugs.
Eisai and partner Biogen Inc.’s rollout of Leqembi has been slowed by logistical issues, uncertainty about repayment and complex safety testing requirements. Medicare, the U.S. health insurance program for seniors, did not routinely cover the treatments until recently, and hospital neurology programs are not set up to do the monitoring needed to use the drugs.
