Eli Lilly to seek US approval after Alzheimer’s drug trial success

Eli Lilly will apply for regulatory approval of an Alzheimer’s drug that a clinical study showed can slow the progress of cognitive decline in patients in the early stages, raising hopes for a new treatment to manage the disease.

For patients in a late-stage trial, the drug called donanemab slowed progression of the disease by 35 per cent compared with those who took the placebo during an 18-month treatment period. The decline in patients’ ability to perform daily tasks was 40 per cent lower for those on the drug.

However, the drug displayed severe side effects such as brain swelling and bleeding and three people on the trial died.

The results of the closely watched trial mark the second significant breakthrough in a year for a drug aiming to treat a disease with about 50mn sufferers worldwide.

US regulators in January approved one of the first new treatments for Alzheimer’s in decades when they gave the green light to lecanemab, a drug co-developed by Japanese drugmaker Eisai and US biotech Biogen.

Both of the drugs work by reducing the build-up of sticky plaques in the brain known as beta-amyloid, which are at the centre of an acrimonious scientific debate about what causes Alzheimer’s disease.

Patient uptake of lecanemab remains very low due to its high price tag — $26,500 a year — and tough restrictions on reimbursement by US government-funded health schemes. Negotiations on government reimbursement, which are critical to the drug’s success, are continuing.

Michael Yee, analyst at Jefferies, said the strong efficacy shown by Lilly’s drug should help persuade US government officials to allow public-funded insurance policies to reimburse the new class of drugs, which treat Alzheimer’s by reducing amyloid plaques.

“It should leave little doubt in minds that these amyloid-lowering drugs have good efficacy for patients and further de-risk the amyloid hypothesis for Alzheimer’s,” said Yee, adding that it would lead to more long-term uptake of both drugs.

Shares in Lilly climbed more than 4 per cent on Wednesday, while Biogen shares rose nearly 2 per cent.

The Alzheimer’s Association said the results from the Lilly trial were the “strongest” released to date for an Alzheimer’s drug and suggested an “inflection point” for treatment of the disease.

Lilly said the Trailblazer-Alz 2 trial met all its goals and that it would apply for regulatory approval to the US Food and Drug Administration before the end of June. The trial enrolled 1,182 people with early-stage Alzheimer’s, and 552 people with a later stage of the disease.

When both of these groups were combined, donanemab slowed progress of the disease by 22 per cent.

Lilly’s chief executive David Ricks told CNBC he expected full approval of donanemab by the end of the year and it would be priced at a similar range as other Alzheimer’s treatments.