Lilly hopes for positive FDA news on Alzheimer’s drug as stock sets new high

For more than three years, Eli Lilly and Co. has been talking about its latest experimental drug for Alzheimer’s disease, and how the drug might finally be the breakthrough medicine for the dread disease.

The company might finally get an answer—or the first clues to an answer–this week.

On Monday, a panel of advisers to the U.S. Food and Drug Administration met to discuss the scientific benefits and risks of the drug, called donanemab. They will offer a recommendation to the FDA on the drug’s approval.

The panel, known as FDA Peripheral and Central Nervous System Drugs Advisory Committee, could vote as early as Monday afternoon.

In response, Lilly’s stock set yet another high, $861.44 per share in afternoon trading on Monday, up $11.45, as investors seemed to sense a favorable ruling.

Analysts say the drug, called “dona” for short, could top sales of $5 billion annually.

The panel will be voting on two questions, according to Cantor Fitzgerald analyst Louise Chen:

• Does the available data show donanemab is effective for the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia?
• Do the benefits outweigh the risks of donanemab in the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia?

“Dona will probably get the nod, but let’s see what (the) label could look like,”  Chen wrote in a note to clients on June 6.

She added: “One debate we have had with some investors is how broad LLY’s label for donanemab will be in light of the FDA’s discussion questions/comments in its briefing document.”

She outlined some concerns, including the dosing regimen, identifying subgroups of patients for whom the risk-benefit analysis might be more or less favorable, and uncertainty regarding the optimal treatment regimen for monoclonal antibodies targeting aggregated amyloid once amyloid levels have been reduced to a level that corresponds with a negative visual read on PET imaging.

All of the FDA’s stated concerns could lead to issues with actually the launching the drug, some analysts say.

“Approval Looks Likely; Launch To Be a Grind,” James Shin, analyst at Deutsche Bank, wrote to clients on June 6.

Lilly has said the clinical results showed the drug was effective in slowing decline in cognition and daily function and for clearing large amounts of sticky plaque, known as beta amyloid, from the brain, as measured by imaging. The plaque, which builds up between the nerve cells of the brain, is one of the hallmarks of Alzheimer’s disease.

Lilly officials have said they are “incredibly confident” in the drug’s potential and the fact that it “offers very meaningful benefits to people with early symptomatic Alzheimer’s disease.”

The results of that most recent trial, known as TRAILBLAZER-ALZ 2 were published in the Journal of the American Medical Association. The trial enrolled 1,736 participants across eight countries.

Lilly said the patients were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography imaging. The patients ranged in age from 60 to 85, with early symptomatic Alzheimer’s disease.

Lilly has said the key risk associated with donanemab is amyloid-related imaging abnormalities, which can be serious and life-threatening. Other reported risks included infusion-related reactions, headache and nausea.

The company had hoped to get a green light on donanemab in the first half of this year, but that is likely to be delayed until later in 2024.