While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers.
That’s proven true in obesity, where the company recently introduced its dual-action GIP/GLP-1 agonist Zepbound against Novo Nordisk’s Wegovy. And the situation is shaping up to be much the same in Alzheimer’s disease, Lilly’s chief scientific and medical officer, Daniel Skovronsky, M.D., Ph.D., said on the sidelines of the 42nd annual J.P. Morgan Healthcare Conference last week.
Donanemab, Lilly’s answer to Eisai and Biogen’s anti-amyloid antibody Leqembi, is poised for a potential FDA approval in the first quarter of 2024, Skovronsky said in an interview.
While Lilly won’t be the first to tap into a new class of neurodegenerative disease-fighting drugs, the company could benefit from being the second mover in the burgeoning Alzheimer’s disease market, the executive figures.
“There’s a market build that needs to happen,” Skovronsky said. “Doctors need to learn how to use this class of drugs and they need to learn how to diagnose.”
The exec pointed to reimbursement and side-effect management as fields where work remains to be done. And while Eisai and Biogen have naturally done some of the heavy lifting already, “I hope that when we launch Lilly can do more,” Skovronsky said.
“This is not a situation, I think, where we’re focused on competing for market share,” he added. “I don’t regret having a competitor in this space.”
In fact, Skovronsky wishes there was even more competition in Alzheimer’s disease, which he believes would spur greater innovation.
Skovronsky pointed to Novo Nordisk for comparison in diabetes and obesity, describing the rivalry as a “classic example of two companies that challenge each other to perform better innovation on behalf of patients.”
The CSO/CMO’s comments echo those made by Lilly’s CEO David Ricks at this year’s JPM conference. Speaking on the topic of obesity, Ricks last week touted his company’s “tremendous respect” for its diabetes and weight loss rival Novo Nordisk.
“I think here's a case where probably competition spurs us both on to go faster and build out more indications and really take the insight—which, credit to Novo, was to exploit high-dose GLPs to pursue weight loss, noticing the separation between A1C and weight loss at the higher doses and we're following them and driving that and I think the world would benefit from that,” Ricks said.
Ricks added that the companies are not fighting over a “fixed pie,” but instead using their combined powers to advance the GLP-1 field into other health challenges like cardiovascular risks and sleep apnea.
In Alzheimer's disease, meanwhile, Lilly knows donanemab and Leqembi are just the start, Skovronsky said.
“We know that even with great drugs like I hope donanemab will be … we won’t have completely solved the problem,” he explained.
“We want to continue to bring forward new medicines for Alzheimer’s and related neurodegenerative diseases,” Skovronsky explained, adding that “our internal pipeline is strong, but where we see great ideas on the outside, we’ll bring them in.”
While Lilly has reason to be optimistic about its drug candidate, it hasn't all been smooth sailing for donanemab. Last January, the company's Alzheimer's candidate lost its bid for an accelerated approval at the FDA, which the regulator blamed on the limited number of patients who had received at least 12 months of drug exposure in a clinical study.
Lilly’s application was based on a mid-stage study that showed a decrease in amyloid plaques within the brain, which has been used as a surrogate biomarker for efficacy against Alzheimer’s. Therapies can snare approval under the FDA's accelerated pathway based on biomarker evidence, assuming the company conducts a confirmatory trial to demonstrate stronger efficacy in the future.
Now, the company is banking on a full approval backed by data from its phase 3 trial TRAILBLAZER-ALZ 2, which Lilly proclaimed set a new standard when the study read out last May. In the study, the main patient population had a 35% slowing of cognitive decline. Donanemab also led to a 36% slowing of decline over 18 months on a key secondary endpoint measured by the Clinical Dementia Rating-Sum of Boxes, or CDR-SB, which calculates disease severity.