Eli Lilly’s Alzheimer’s super drug Donanemab to be approved in days

US regulators are close to approving Eli Lilly’s Donanemab, which promises to slow the onset of dementia. Australia should follow this year, the drug giant’s global CEO says.

Eli Lilly’s Alzheimer’s drug promises to slow the progression of early onset dementia.

The pharma giant behind breakthrough Alzheimer’s drug Donanemab expects approval to come from US regulators “any day” with Australian approval to follow later this year.

The drug that passed its final trial tests last year has shown to slow the progression of the early stages of Alzheimer’s, with the debilitating disease now emerging as one of the leading causes of death, particularly for women.

The treatment represents the next blockbuster drug for US pharma giant Eli Lilly, which has staged a stunning share surge since it published its final Donanemab results last May. The pharma is also getting a boost from its newly released weight-loss drug Mounjaro.

Eli Lilly global chief executive David Ricks said studies showed the drug has the potential to slow progression of the disease by a third in early onset. And the figure is higher for treatment with very early stage diagnosis.

“We’ve invested nearly $US10bn on mostly failed research to try to conquer Alzheimer’s because it’s such a terrible condition,” Mr Ricks told The Australian in an interview. “It’s fatal. It deprives the individual and the family of those golden years of life and it’s hugely expensive for society.

“Here’s a breakthrough that could make a difference.”

David Ricks, global chair and CEO of Eli Lilly in Sydney. Picture: John Feder

The global body representing Alzheimer’s researchers, the Dutch-based Alzheimer’s Association, said the results of the Donanemab trials demonstrate “an important advancement” in research and treatment of the disease. The association said the potential for slowing the progression of the disease “gives people more time to participate in daily life and remain independent”.

Eli Lilly is ranked as the world’s biggest drug maker with a market value pushing $US760bn ($1.1 trillion) in the past week. Even with approval for Donanemab still forthcoming, Mr Ricks said his scientists have research underway using the same medication that is also looking at prevention for Alzheimer’s among those considered to be at a higher risk of getting the disease.

The pending release of the high-cost drug – and application for subsidies through the Pharmaceutical Benefits Scheme to make it available to more people – is set to stoke the debate around the value of medication.

Mr Ricks said the success of drugs like Donanemab, which has been decades in development, or Lilly’s weight-loss drug Mounjaro, is built around a heavy financial investment in research. And they provide the financial footing to reinvest in the next major drug. Lilly is considered a leader in Alzheimer’s, but its drug research pipeline also extends to diabetes, cancer and other neurological conditions. Almost half of the research program is in collaboration with outside agencies, which is a cultural shift in approach for a major pharma player.

He says the drug should be considered not just in terms of direct pharmaceutical funding, but the wider benefits of the entire healthcare chain. In the case of dementia care, it will free up capacity in intensive nursing and aged care beds.

“In the case of obesity. There’s a few different dynamics but one thing we do hope to prove to displace is medical care costs for people with obesity by reducing their weight. Starting with cardiovascular outcomes to knee and joint replacements,” Mr Ricks said.

“We would argue that’s a useful thing. Those things are always inflating because they’re based on labour or capital. Whereas medicines eventually get very cheap when they go generic.”