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Eli Lilly Gets US Nod for Early-Stage Alzheimer’s Treatment

Eli Lilly Gets US Nod for Early-Stage Alzheimer’s Treatment

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After obtaining US permission on Tuesday, Eli Lilly is preparing to sell its Alzheimer’s treatment for early-stage patients. The company is providing the medicine at a significant premium over a competitor, claiming it is more efficient. The therapy, marketed in the US under the brand name Kisunla, will be available to patients one year after launching the first medicine to treat the neurodegenerative condition, created in collaboration with Biogen and Eisai.

The medication lessens the progression of Alzheimer’s disease, a neurodegenerative disease that causes impairments in memory, thinking, and behavior. Around seven million Americans are living with Alzheimer’s disease. Eli Lilly’s medicine will be available to more than 1 million late-stage patients. Kisunla, whose official name is Donanemab, will have a $32,000/year listing fee for treatment, 20% more than Leqembi’s $26,500/year.

Reasoning that health systems save money since the medication usually requires fewer infusions than Leqembi, Eli Lilly’s neuroscience division head, Anne White defended the higher price in an interview. Both therapies are effective because they target the protein amyloid plaque, which accumulates in the brains of people with Alzheimer’s disease. White explained that Eli Lilly’s treatment allows patients “to stop and not continue to pay drug costs” since it requires less frequent infusions than Leqembi, freeing up capacity, and because patients may come off it after eliminating amyloid.

“There are no head-to-head studies; therefore, we cannot make comparisons between therapies,” an Eisai official said before saying that a doctor considers several criteria when deciding which medication to administer. In the third and final stage of the experiment, kisunla reduced cognitive loss by 35%.

After a year, over half of the study participants eliminated amyloid, enabling them to stop the medication (the cognitive impairment associated with amyloid still exists). Some analysts have become bearish about the success of Kisunla, warning doctors that they may be less likely to prescribe the medicine because of a higher incidence of rare side effects, including brain swelling, compared with Leqembi, which is expected to launch next year. A more convenient, subcutaneous version could also eclipse the medicine. Suggesting it may fall short of the so-called “blockbuster” status of $1 billion in sales and considerably below analysts’ average predictions of $3.7 billion for 2030, Leerink analysts trimmed their 2030 sales projection for Kisunla to $500mn.

Earlier this year, the Food and Drug Administration postponed approving the medication until a team of independent experts reviewed it. Still, Eli Lilly’s market value—more than $850 billion—remains close to all-time highs driven by a significant windfall from a new class of diabetes and weight-loss medications Mounjaro and Zepbound. Medicare, a US government-backed healthcare program for over-65s, indicated last year that, should it get complete regulatory clearance, it will cover Kisunla and imaging tests required to verify patient eligibility to get the medication. Lesbi will cost the program $550mn this year and $3.5 billion in 2025.

Leqembi has been challenging to roll out, especially since Medicare Advantage plans—which cover 30.8mn over-65s on the scheme—have objected to financing the expensive scan. White said that there was “good movement” on scans covered with “almost all patients processing claims successfully.” She noted, however, “the heavier lift is making sure that people are aware that there is coverage, making sure that they have a place where they can refer patients for care and making sure that they get good reimbursement for that.”

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