Eli Lilly & Co.’s Alzheimer’s treatment has been approved in the United States as 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 its investors, who have been eagerly awaiting the drug since its launch. showed promise More than three years ago, the Kisunla drug entered clinical trials and faced several regulatory delays before being approved. It will compete with Eisai Co.’s Leqembi, which tested positive for COVID-19. 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 surged more than 50% year-to-date before today, amid rapid growth in sales of weight-loss and diabetes products. Shares of Eisai partner Biogen Inc. fell 1.3%
The Alzheimer’s drug will cost $32,000 for the first year of treatment, Lilly said. That’s slightly more than Leqembi’s $26,500 annual price tag for an average person. But doctors can stop the treatment if brain plaques — the toxic substance the drug removes — fall to minimal levels, which happened in many people in trials after about a year.
Lower costts
That means the total out-of-pocket cost of treatment could sometimes be lower than for other anti-amyloid drugs, Lilly said. In Leqembi’s main approval trial, patients were treated for 18 months.
Both the Eisai and Lilly products are infusions that clear 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 disease that can be treated with infusions. minority of the total population of patients with the disease. Side effects of both diseases include swelling and brain hemorrhage.
Brain swelling or bleeding occurred in 36% of patients treated with Lilly’s drug in the company’s main study, and caused symptoms in 6%, according to the drug’s label. Regular checkups are needed to monitor these effects. Lilly’s drug has a potential advantage in convenience because it is given every four weeks, compared with every two weeks for Leqembi.
Less frequent doses and the ability to stop treatment are “a very important issue,” Howard Fillitco-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 getting Kisunla to market. In early 2023, the FDA denied Lilly announced that it wanted accelerated approval for the drug 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 one-day hearing to examine the drug’s safety and effectiveness.
A panel of external advisors to the FDA voted unanimously in favor of the drug on June 10.
“There is a lot of emotion in the corridors today” Anne WhiteLilly Neuroscience president and CEO said in an interview before the approval. “We have portraits of our family members on our walls to remind us why we do what we do.”
Once considered central to Lilly’s future, Alzheimer’s disease has been eclipsed by the company’s GLP-1 drugs that help with weight loss, a market that is expected to reach $130 billion a year by the end of the decade, according to analysts at Goldman Sachs.
Sales of Alzheimer’s drugs are also expected to see significant growth. Bloomberg Intelligence analysts predict sales will reach $13 billion by 2030, up from about $250 million this year.
“Having multiple treatment options is the kind of breakthrough we’ve all been waiting for, all of us who have been touched, or even blindsided, by this difficult and devastating disease,” Joanne Pike, CEO of the Alzheimer’s Association, said in a statement. The nonprofit has lobbied for approval of amyloid-lowering drugs and expanded coverage.
The rollout of Leqembi by Eisai and its partner Biogen Inc. has been slowed by logistical problems, Reimbursement uncertainties and complex safety testing requirements. Medicare, the U.S. health program for seniors, did not routinely cover the treatments until recently, and hospital neurology programs were not set up to provide the oversight required to use the drugs.
