Eli Lilly & Co. has won U.S. approval for an Alzheimer’s treatment, the second drug to slow the progression of the brain-robbing disease that affects 6 million Americans.
It’s a huge win for Lilly and its investors, who have been eagerly awaiting the drug since it hit the market. show promise Clinical trials on the drug have been underway for more than three years. The drug, called Kysonla, has endured a number of regulatory delays on its way to approval. It will compete with Eisai’s Lekme, which has been temporarily halted. Available for sale In the United States since early 2023.
Shares of Indianapolis-based Lilly closed down 0.8% Tuesday in New York. The stock had risen more than 50% so far this year before today amid rapid growth in sales of its weight-loss and diabetes drugs. Shares of Eisai’s partner Biogen Inc. fell 1.3%.
The Alzheimer’s drug will cost about $32,000 for the first year of treatment, Lilly said. That’s slightly more than the $26,500 annual price tag for Lekme for the average person. But doctors can stop treatment if brain plaques—the toxic material the drug removes—drop to minimal levels, which happened for many people in the trials after about a year.
low costT.S
That means the total cost of treatment with this drug can sometimes be lower than other amyloid treatments, Lilly said. In Lekme’s main approval trial, patients were treated for a full 18 months.
Eisai and Lilly’s products are injections that remove toxic amyloid from the brains of Alzheimer’s patients. They slow the disease only modestly, and are approved only for people with early-stage Alzheimer’s, a rare disease. minority Of the total number of patients with this disease. Side effects of both diseases include brain swelling and bleeding.
Swelling or bleeding in the brain occurred in 36% of patients taking Lilly in the company’s main study, and led to symptoms in 6% of them, according to the drug’s label. Regular checkups are required to monitor these effects. Lilly has the potential convenience advantage of being injected every four weeks, compared with Lekmebi’s every two weeks.
Reducing doses and potentially stopping treatment is “really big.” Howard VeilletteJohn Curry, co-founder of the Alzheimer’s Drug Discovery Foundation, said in an interview before the approval:
series of delays
Lilly has faced a series of delays in bringing Kysonla to market. In early 2023, the FDA issued a statement to reject Earlier this year, the FDA scheduled a full-day hearing to review the drug’s safety and efficacy after the company said it wanted to wait until a late-stage trial. When Lilly submitted that data, the FDA needed more time to review it. Then, late in the review process, the agency scheduled a full-day hearing to review the drug’s safety and efficacy.
A panel of outside advisors to the FDA Voted unanimously For the benefit of medicine on June 10.
“There’s a lot of emotion in the hallways today.” Anne White“We put pictures of family members on our walls to remind us why we do what we do,” Lilly Neuroscience’s president said in an interview before the approval.
Alzheimer’s disease was once considered an integral part of Lilly’s future, but the company’s GLP-1 drugs that aid weight loss have overshadowed that disease, a market that is expected to grow rapidly. Up to $130 billion By the end of the decade, according to analysts at Goldman Sachs.
Sales of Alzheimer’s drugs are also expected to grow significantly. Bloomberg Intelligence analysts expect sales to rise 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 are affected, even if indirectly, by this devastating and difficult disease,” said Joanne Pike, CEO of the Alzheimer’s Association, in a statement. The nonprofit has pushed hard for broad approval and insurance coverage of amyloid-lowering drugs.
The rollout of Leqembi by Eisai and partner Biogen Inc. has been slowed by logistical issues, Uncertainty about payment Sophisticated safety testing was urgently needed. Until recently, the U.S. Medicare program for the elderly did not routinely cover these treatments, and hospital neurology programs were not equipped to do the necessary monitoring of drug use.