Eli Lilly & Co.’s Alzheimer’s Treatment it was cleared in the US as a second-line drug to slow the progression of the dementing disease that afflicts 6 million Americans.
It’s a big win for Lilly and its investors, who have been eagerly awaiting the drug since it showed promise in a clinical trial more than three years ago. Called Kisunla, the drug endured several regulatory delays on the road to approval. It will compete with Eisai Co.’s Leqembi, which has been available for sale in the US since early 2023.
Shares of Indianapolis-based Lilly closed up 0.8% on Tuesday in New York. The stock is up more than 50% so far this year earlier today amid rapid growth in weight loss and diabetes sales. Shares of Eisai’s partner Biogen Inc. down 1.3%.
The Alzheimer’s drug will cost $32,000 for the first year of treatment, Lilly said. That’s slightly more than the $26,500 Leqembi annual price for an average-sized person. But doctors can stop treatment if plaques in the brain – toxic substances removed by the drug – fall to low levels, which they did in many people in trials after a year.
Lower costs
That means the drug’s out-of-pocket treatment costs can sometimes be lower than other amyloid drugs, Lilly said. In Leqembi’s main clinical trial, patients were treated for a full 18 months.
Eisai and Lilly products are both infusions that remove toxic amyloid from the brains of Alzheimer’s patients. They only modestly reduce the disease and are only approved for people with Alzheimer’s disease, which is a minority of the total number of patients with this disease. Side effects of both include brain swelling and brain bleeding.
Brain swelling or bleeding occurred in 36% of patients on Lilly’s drug in the company’s main study, and produced symptoms in 6% of them, according to the drug’s label. Regular scans are needed to monitor these effects. Lilly’s drug has the potential advantage of being administered every four weeks, compared to Leqembi’s every two.
The reduction in frequent dosing and the possibility of stopping treatment is “a really big deal,” Howard Fillit, founder of the Alzheimer’s Drug Discovery Foundation, said in an interview before the approval.
A series of delays
Lilly faced a series of delays bringing Kisunla to market. In early 2023, the FDA refused to grant accelerated approval for the drug based on the results of an early trial, telling the company it wanted to wait for a later trial. When Lilly submitted that data, the FDA needed more time to review it. Earlier this year, the agency decided late in the review process to call a day-long hearing to review the drug’s safety and effectiveness.
The FDA’s external advisory panel voted unanimously in favor of the drug on June 10.
“There’s a lot of emotion in the hallways today,” said Anne White, president of Lilly Neuroscience, in an interview before the concession. “We have pictures on the walls of family members to remind us why we do what we do.”
Considered key to Lilly’s future, Alzheimer’s has been overshadowed by the company’s GLP-1 weight loss drug, a market expected to reach $130 billion a year by the end of the decade, according to Goldman Sachs analysts.
Sales of Alzheimer’s drugs are also expected to grow significantly. Bloomberg Intelligence analysts see sales rising to $13 billion by 2030 from $250 million this year.
“Having more treatment options is the kind of progress we’ve all been waiting for — all of us who have been touched, blindsided, by this difficult and devastating disease,” said Joanne Pike, CEO of the Alzheimer’s Association, in a statement. . The nonprofit organization is pushing hard for the approval and widespread insurance coverage of amyloid-lowering drugs.
The release of Leqembi by Eisai and its partner Biogen Inc. reduced planning problems, uncertainty of returns and complex safety testing requirements. Medicare, the US health plan for the elderly, did not cover the treatment until recently, and hospital neurology programs were not set up to perform the necessary monitoring for drug use.
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