Eli Lilly & Co.’s Alzheimer’s drug has become the second drug approved in the United States to slow the progression of the mentally debilitating disease that affects 6 million Americans.
This is a huge win for Lilly and its investors, who have been eagerly awaiting the drug since it was first announced. showed promise The drug, called Kisunla, which was in clinical trials three years ago, suffered several regulatory delays before winning approval. It will compete with Eisai Co.’s Leqembi. Available for sale It is expected to be implemented in the United States starting in early 2023.
Shares of Indianapolis-based Eli Lilly fell 0.8% in New York Tuesday. The stock had soared more than 50% this year before today amid rapid growth in weight-loss and diabetes sales. Shares of Eisai partner Biogen Inc. fell 1.3%.
Lilly said the first year of treatment for Alzheimer’s disease will cost $32,000. That’s slightly more than the $26,500 annual price for an average-sized person taking Leqembi. But doctors can stop treatment once the brain plaques (toxic substances the drug removes) have dropped to minimal levels, which many people have done after about a year.
low cosTS
That means the total out-of-pocket cost of the drug could sometimes be less than for other amyloid drugs, Lilly said. Patients in Leqembi’s pivotal approval trial were treated for 18 months.
Both the Ace and Lilly products are injectables that remove toxic amyloid from the brains of Alzheimer’s patients. These products only slightly slow the disease and are only approved for patients with early-stage Alzheimer’s. decimal In the overall patient population with the disease. Side effects of both include cerebral edema and cerebral hemorrhage.
In the company’s main study, 36% of patients taking Lilly’s drug developed brain swelling or bleeding, and 6% of them, according to the drug label. Regular checkups are needed to monitor these effects. Lilly’s drug may have the advantage of convenience because it is given every four weeks, unlike Leqembi, which is given every two weeks.
Less frequent dosing and the possibility of stopping treatment are “a really big problem” Howard Fillitt“It’s a very promising idea,” he said in an interview before the approval, adding that the co-founder of the Alzheimer’s Drug Discovery Foundation:
A series of delays
Lilly has faced a series of delays in bringing Keysunra to market. In early 2023, the FDA Rejected The FDA granted accelerated approval for the drug based on early-stage results, telling the company it wanted to wait for later-stage trials. When Lilly submitted the data, the FDA needed more time to review it. Then, earlier this year, the FDA decided to hold a day-long hearing to review the drug’s safety and efficacy later in the review process.
FDA’s Outside Advisory Panel Voted unanimously I approved the drug on June 10th.
“There was a lot of emotion in the hallway today.” Anne White“We have portraits of family members on our walls to remind us why we do this,” Lilly Neuroscience’s president said in an interview before the approval.
Alzheimer’s disease was once seen as a frontrunner for Lilly’s future, but the market is expected to expand as it is overshadowed by the company’s GLP-1 drug, which helps with weight loss. Reaching $130 billion According to Goldman Sachs analysts, it could take less than a year before the decade ends.
Sales of Alzheimer’s drugs are also expected to increase significantly. Bloomberg Intelligence analysts expect sales to soar from about $250 million this year to $13 billion by 2030.
“Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been affected by, or even bewildered by, this difficult and devastating disease,” Alzheimer’s Association CEO Joanne Pike said in a statement. The nonprofit has been working hard to get approval and widespread coverage for amyloid-lowering drugs.
The launch of Eisai and partner Biogen Inc.’s Leqembi has been delayed due to logistical issues. Refund uncertainty And complex safety testing requirements. Medicare, the U.S. health program for seniors, did not routinely cover the treatment until recently, and hospital neurology programs were not set up to perform the monitoring necessary to use the drug.
