Lilly’s Alzheimer’s drug shows promising results with 35% reduction in disease progression

USA — Eli Lilly’s experimental Alzheimer’s drug, donanemab, has shown promising results in slowing the cognitive decline associated with the disease in a late-stage trial, demonstrating that the removal of sticky amyloid plaques from the brain can benefit patients with the fatal disease.

This drug is expected to become the third of its kind on the market following the U.S. approval of two similar medicines, Leqembi and Aduhelm, developed by Eisai and Biogen.

The drug met all goals of the trial and slowed progression of Alzheimer’s by 35% compared to a placebo in 1,182 people with an early-stage disease whose brains had deposits of two key Alzheimer’s proteins, beta-amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death.

Additionally, the study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on the Clinical Dementia Rating Scale (CDR-SB), a commonly used scale of dementia progression.

Experts said Lilly’s findings were roughly on par with Eisai Co Ltd. and Biogen Inc’s lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer’s in a study published last year.

However, it’s essential to note that the donanemab treatment group reported brain swelling, a known side effect of drugs of this type, in 24% of participants, with 6.1% experiencing symptoms.

Brain bleeding occurred in 31.4% of the donanemab group and 13.6% of the placebo group. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants.

Lilly said the incidence of serious brain swelling in the donanemab study was 1.6%, including two deaths attributed to the condition, and a third after an incident of serious brain swelling.

Lilly plans to file for traditional U.S. approval by the end of June and with regulators from other countries shortly thereafter.

The company said a U.S. approval decision should come by year-end or early 2024.

Alzheimer’s experts have eagerly awaited the full results of the study, including data on how the drug performs in people who carry an Alzheimer’s risk gene known as APOE4, who have been prone to increased risk of side effects in prior trials.

Those results are set to be presented at an Alzheimer’s meeting in Amsterdam this summer.

Study participants received a monthly intravenous infusion of donanemab, and after 12 months, half had no evidence of amyloid plaques.

The company also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

Two similar medicines developed by partners Eisai and Biogen – Leqembi as well as Aduhelm have failed to gain traction with doctors or insurers after showing little evidence that they slowed cognitive decline.

Specifically, Aduhelm has failed to gain traction with doctors and insurers due to its high cost and the controversy surrounding its approval by the FDA.

Leqembi, which costs US$26,500 per year, is less expensive than Aduhelm, which initially cost US$56,000 per year.

After strong objections from the FDA’s panel of outside advisers, Biogen eventually slashed the price of Aduhelm in half to US$28,000 annually.

Both drugs were approved under the FDA’s accelerated review program, based on their ability to remove amyloid plaques.

With more than 6 million Americans living with Alzheimer’s, and that number projected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association, there is an urgent need for effective treatments.

Lilly’s CEO David Ricks has stated that the company is still finalizing the price for donanemab but plans for it to be in the same range as other similar therapies.

The reception of donanemab by doctors and insurers will likely depend on its cost and effectiveness compared to other treatments on the market.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.