Eli Lilly stock jumped Monday after advisors to the Food and Drug Administration said the benefits of Alzheimer's treatment donanemab outweigh the risks for most patients.
All 11 members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted that the evidence from clinical trials supports the effectiveness of Lilly's donanemab for patients with Alzheimer's disease. The panel later voted unanimously that the benefits of donanemab outweigh the risks for the types of patients Lilly studied in its trials.
Eli Lilly stock gained 1.8% during the regular session, closing at 865 just after the final vote wrapped. Shares rose a fraction in after-hours action.
Eli Lilly Stock: Risks Are Key
Donanemab, like Biogen and Eisai's Leqembi, works by removing built-up plaque in the brain known as amyloid beta. Amyloid beta is a hallmark of Alzheimer's disease. But removing it can lead to brain swelling known as amyloid-related imaging abnormalities, or ARIA.
In Lilly's Phase 3 study, 31.4% of patients experienced ARIA-H, characterized by microhemorrhages. Just 13.6% of placebo recipients had the same.
Patients who have two copies of a gene called APOE4 are more likely to develop Alzheimer's disease at a younger age. Kathleen Poston, a panelist, noted their progression is "a bit more ominous." She, and other panelists, supported giving physicians, patients and their families the opportunity to make their own decision about the benefits and risks of donanemab treatment.
Another panelist noted physicians treating older adults are often cautious.
The first rule of medicine is "do no harm," she said. But there are some "very brisk older adults and younger adults who deserve that chance to have a discussion with their clinician and really weigh those benefits and risks."
Tau Discussion Benefits Eli Lilly Stock
It's important to note, donanemab works better in patients who have evidence of a protein called tau in their plaque buildup. In Lilly's final study, donanemab recipients had a 29% slower decline in cognition over 18 months, compared to 27% in Biogen and Eisai's final Leqembi study.
Among patients with intermediate levels of tau, donanemab slowed cognitive decline by 36% to 37%. Lilly didn't test donanemab in patients with no or very low levels of tau. Further, patients with high tau levels didn't meet the primary bar in the study, though did show some benefit.
Bullishly for Eli Lilly stock, the panel didn't recommend a restricted label for donanemab. In fact, many said recipients of the potential Alzheimer's treatment shouldn't have to undergo regular monitoring for tau levels.
"The vast majority of the committee feels as though imposing a requirement for tau imaging is not necessary and would raise serious practical concerns and access concerns to the treatment," Chairperson Thomas Montine said during the meeting.
Public Comments Lean In Favor
Most public comments were in favor of approving donanemab.
PharmedOut.org representatives were on the opposite side, though, noting the panelists previously voted against recommending the agency sign off on Biogen's now-defunct Alzheimer's drug, Aduhelm. They recommended the same outcome for donanemab.
Meanwhile, commentary from a 79-year-old man with mild cognitive impairment due to Alzheimer's disease really drove home the potential benefit-risk analysis patients have to make.
He was managing his disease "but fearful of further mental decline," so he enrolled in a study of Lilly's donanemab.
Following treatment, "my amyloids have now completely cleared, but this was not an entirely smooth road." After about the ninth infusion, his arm began shaking uncontrollably and he could feel his blood pressure rise. He was later released from the emergency room with no apparent damage.
He still recommended approval of donanemab.
'Not A Miracle Cure'
The primary investigator for three donanemab studies — who said she wasn't being compensated for her testimony — noted ARIA can be managed "safely and well," and occurred in placebo patients too.
"Donanemab is not a miracle cure," she said. "It does not stop cognitive decline. But it could be part of an effective cocktail and we've got to start somewhere."
Eli Lilly stock is trading at a record high with a Relative Strength Rating of 94 from IBD. This means Lilly shares have performed in the top 6% of all stocks over the past 12 months.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
