Eli Lilly aims to introduce Alzheimer’s drug Donanemab in India in near future: CEO Dave Ricks

American pharmaceutical giant Eli Lilly plans to introduce its Alzheimer’s drug, Donanemab, in India in near future, pending expected USFDA approval in the next week or two, Dave Ricks, CEO of Eli Lilly told Business Today in an exclusive interview.

Being one of the market leaders in the anti-obesity and diabetes space, Lilly is also foraying into Alzheimer’s space with Donanemab. “We are waiting, actually, in the next week or two for US approval. We will introduce it in India as well as around the world. We expect that first, and then we will submit in many of the other markets and hope to have that available globally next year,” said Ricks.

Alzheimer’s currently lacks a cure, but there are medications to help manage symptoms and potentially slow its progression. These drugs primarily fall into two categories: acetylcholinesterase inhibitors and memantine, which regulate neurotransmitters crucial for memory and learning. Some patients may receive a combination of both, according to doctors.

Eli Lilly’s Donanemab is a promising drug undergoing clinical trials for early-stage Alzheimer’s. It’s a monoclonal antibody designed to target and remove beta-amyloid plaques, a key feature of the disease.

“We have been working on Alzheimer’s for over 30 years, my entire career, and mostly we have failed, and we have spent a lot of money, almost $10 billion in research just on Alzheimer's. But sometimes you fail forward, you learn something, and you can adapt, given the scourge of Alzheimer's,” said Ricks.

“And, in fact, there's really nothing that treats it. It's a fatal condition from diagnosis until death, typically within seven years. And those seven years are miserable. So we feel compelled to work in this space.Fortunately, last year, we completed a final test of our Alzheimer's drug, Donanemab, and it had a profound impact on people living with dementia,” said Ricks.

Recent Phase 3 trials have shown positive results in slowing cognitive decline. However, donanemab is not yet available commercially, and further research is needed to confirm its long-term benefits and safety, as per the scientists.

A recent study published in The New England Journal of Medicine (NEJM) included 257 patients with early Alzheimer's disease. Some received donanemab (131 patients), while others got a placebo (126 patients). The baseline score was similar for both groups. After 76 weeks, those on donanemab showed a better improvement in cognitive and daily living scores compared to the placebo.

However, other outcomes didn't consistently differ. Donanemab also reduced amyloid plaque levels more than the placebo. Some patients on donanemab experienced side effects like cerebral edema, the study said which was funded by Eli Lilly.

“Interestingly, we showed in a medical program in July, that people who are younger have less of the bad amyloid plaque in their brain or more mild symptoms, they do even better, up to a 60% slowing of the disease. This is a really important new medicine for Alzheimer's, and we are at the leadership there,” he said.

Besides Eli Lilly, which is developing Donanemab to target beta-amyloid plaques in early stages, other active companies in the segment include Biogen, which co-developed and markets Aduhelm, the first FDA-approved drug targeting beta-amyloid; Eisai, which co-developed Aduhelm and markets Donepezil, a popular acetylcholinesterase inhibitor; Johnson & Johnson, which markets rivastigmine, another frequently prescribed inhibitor; and Pfizer, which markets galantamine, another inhibitor through their acquisition of Medivation.