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If pharmaceutical companies have learned anything about the Alzheimer’s market over the past few years, it’s that FDA approval is by no means a guarantee of success.
As Eli Lilly celebrates Last week’s green light As for Xanra (formerly known as donanemab), which removes amyloid plaques, there is still work to be done to make the drug available to eligible patients.
Pioneers in the field have had a mixture of success and failure. Biogen and Eisai’s Aduhelm had a disastrous initial launch when insurers refused to cover it because of uncertain efficacy and safety. The same companies’ Leqembi was more favorably received, but Slow to meet market expectationsAlzheimer’s is a difficult disease to treat.
“New treatments in the Alzheimer’s field give hope to that community. There is definitely a market for them. We may not have the perfect drugs today, but the first cancer drugs weren’t perfect either.”
Jane Hornung
Chief Clinical Officer, MMIT
Could Lilly make a bigger impact? Some market watchers think it could, despite clinical results showing some patients are at risk for a type of brain swelling called ARIA. Like Aduherm and Requembi, the drug is only available to patients who are in the early stages of the disease and have confirmed amyloid plaques in the brain.
But there’s a special reason why Kishunla stands out from the crowd.
“Kisunra has the backing of Lilly,” said Jane Hornung, chief clinical officer at market-entry consultancy MMIT. “They’re literally a powerhouse that knows how to get a drug to market in the face of information.”
According to a July 2 report from Cantor Fitzgerald analyst Louise Chen, Kisanra is expected to hit $2 billion in annual sales by 2029. That’s roughly the same as Kantor Rekembi’s forecast of roughly $2.2 billion for the same period, even though Kisanra hits store shelves more than a year earlier.
Lilly “is a marketing machine and it will be interesting to see how the launch goes compared to expectations,” Chen wrote.
Xanla is slightly more expensive than Leqenvi, at $32,000 for 13 infusions over a year. Leqenvi is given in indefinitely every two weeks, whereas Xanla can be stopped once the plaque has cleared. In late-stage clinical trials of Xanla, 17% of patients completed treatment at six months, 47% at one year, and 69% at 18 months, Chen said.
A welcome treat — almost
Xanra’s approval was met with an enthusiastic welcome from patient and medical groups who support the introduction of drugs to reduce the burden of Alzheimer’s disease. Alzheimer’s Association, Alzheimer’s Voice And that Alzheimer’s Drug Discovery Foundation He expressed support for the decision.
“When a new treatment is developed in the Alzheimer’s field, it gives hope to the community,” Hornung says, “and there is certainly a market for that treatment. We may not have the perfect drugs today, but the first cancer drugs weren’t perfect either.”
However, some consumer advocacy groups criticized the FDA’s approval. Public Citizen“The FDA should have rejected the drug because of its “moderate” efficacy and “substantial” safety risks. For these reasons, access to Kisunra is appropriately restricted to the specific patient groups who would benefit,” Hornung said, noting that three people died from complications of brain swelling in the late-stage study.
“This is not the best drug for everyone, so patients have to be selected appropriately, but we do that with any drug,” Hornung said. “As the FDA committee suggested, the benefits of this drug outweigh the risks.”
Lilly can learn from similar complications of its drugs, such as Adjuvant and Lexambi, in Alzheimer’s, and even drugs that treat other diseases, such as multiple sclerosis, can serve as comparisons. Sanofi’s MS drug Lemtrada Black Box Warning Hornung noted that the drug had not been developed to treat a brain infection called progressive multifocal leukoencephalopathy, which patients and doctors shy away from, but the setback marks an evolving treatment landscape with new drugs that don’t carry the risk of PML.
“You develop a drug, you learn from it, you understand what causes side effects, then you make changes to the molecule to make a better drug that benefits patients,” Hornung says. “And that’s what’s happening here.”
Targets other than monoclonal antibodies may find their way into the Alzheimer’s field Making progress In the future.
“Scientists understand that there is a link between amyloid plaques and Alzheimer’s disease, and while it may not be a cure, it is helping to slow the progression of the disease in patients,” Hornung said. “That could one day lead to more specifically targeted therapies.”
Payers are also likely to provide access to drugs like Kisunla and Lekuenvi as long as patients are eligible, Hornung said.
“Payers aren’t restricting access like they did with AduHelm,” Hornung says. “They’re finding ways to get this product to the right patients, and they’re not just giving it out freely to everyone with Alzheimer’s.”
