Eli Lilly has told the UK health minister that its new drug has the potential to prevent Alzheimer's.

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Pharmaceutical company Eli Lilly told the then-British health minister last year that its new Alzheimer's drug could be a one-time course of preventive treatment, despite limited data to support that claim, despite a freedom of information request. revealed.

At a meeting with Conservative Minister Victoria Atkins in December 2023, Eli Lilly CEO David Ricks said the company's donanemab drug could end Alzheimer's by treating people diagnosed before symptoms appear. He said there is potential for prevention. This could be done by reducing clumps of amyloid plaque protein in the brain, which are thought to cause the disease, according to minutes released in response to an FOI request.

Atkins noted the drug's game-changing potential.

However, the company has yet to prove this to be true. The study examining the preventive potential of donanemab is not scheduled to end until 2027, a point that was not made clear in minutes provided in the FOI request.

When asked about the timing of the call, Lilly told the Financial Times that it believed it had the potential to treat people diagnosed with Alzheimer's disease before symptoms appear, and that it was validating this through ongoing clinical trials.

The comments come as drug companies are more skeptical in Europe than U.S. regulators about the costs and safety issues of identifying eligible patients and administering new Alzheimer's drugs after the European Medicines Agency rejected a competing treatment. It was revealed as I faced the vision.

In a wide-ranging discussion, Ricks also told Atkins that donanemab is a course of treatment and that it takes decades for amyloid plaques to build up again after treatment.

Amyloid builds up slowly in the brains of Alzheimer's patients, but because donanemab has only been tested in recent years, it is unknown whether it is a complete cure.

Several experts said it was still difficult to say whether the drug had preventive potential and its long-term benefits had not been proven.

Lilly told the FT: “Ongoing trials exploring the drug's preventative potential include nine monthly doses.” [delivered by infusion]After this, treatment is stopped. He added that it would likely take years for amyloid to build up after it was cleared.

Atkins said meeting companies like Eli Lilly has been one of the most exciting parts of her role in understanding the advancement and treatment of diseases like dementia.

The meeting was one of several between Eli Lilly and Conservative health ministers in 2023.

Eli Lilly's drug is being reviewed by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to treat people with symptomatic early-stage Alzheimer's disease.

Donanemab and lecanemab, competing treatments developed by Japanese pharmaceutical company Eisai and American biotech Biogen, have both been approved by U.S. and Japanese regulators. However, the European Medicines Agency rejected lecanemab and is still evaluating donanemab.

The MHRA approved lecanemab for use in England last August, but Nice, the cost-effectiveness watchdog of the National Institute for Health and Care Excellence, said the benefits were too small to justify the significant costs and that it should not be prescribed on the NHS. I said I wouldn't do it.

In clinical trials, lecanemab slowed the progression of Alzheimer's disease by 4 to 6 months in people in the early stages of the disease. Donanemab slowed things down slightly.

However, 27% of lecanemab patients and more than one-third of donanemab patients experienced amyloid-related imaging abnormalities (Aria) due to brain swelling and hemorrhage.

In its decision to reject lecanemab, the European Medicines Agency said the severity of this side effect should be considered in the context of the small effects seen by the drug. The MHRA called for testing for genes linked to higher Aria rates.

Another challenge for health care systems is the infrastructure needed to diagnose disease early enough for the drugs to be effective, administer drugs, and monitor patients for side effects.

In his meeting with Atkins, Ricks pointed out that Pet scans, which are used to identify potential patients and monitor their progress, are expensive and that there are not enough Pet cameras to test them on the scale needed.

Eisai is appealing the Nice decision and the EMA ruling. Gary Hendler, head of Emea at Eisai, said regulators should avoid making short-term decisions that could impact R&D in the long term.

Lecanemab is clearly neither a panacea nor a cure. But what are the additional drugs without the first step? Where do you go after that? he said

Anne White, Lily's head of neurology, said she was very disappointed with Lily's response. [lecanemab]. She added that it is almost inconceivable that a new Alzheimer's drug could potentially be available around the world, including in the United States, China, Japan and the United Arab Emirates, and outside of Europe.

EMA and MHRA declined to comment.

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