The Food and Drug Administration's (FDA) 11-member advisory committee unanimously endorsed Monday (June 10) Eli Lilly's Alzheimer's drug, donanemab, for approval in an effort to further slow the aggression of the specific type of dementia in patients.
The Washington Post reported that, while the drug was not able to cure or halt the condition, it could slow by 35% the cognitive and functional decline in people in the early stages of dementia over 18 months.
Eli Lilly vice president Mark Mintun said in a statement that they welcomed the committee's approval and were looking forward to the drug becoming a treatment option to patients in the future.
According to Wall Street analysts, the company's shares also rose 1.8% Monday while the panel members were voting in the affirmative for the drug.
However, Leerink Partners analyst David Risinger noted that the drug had a questionable competitive profile.
FDA's Verdict on Eli Lilly's Dementia Drug
It was revealed that the committee discussed the safety of donanemab, which aims to clear a sticky plaque from the brain called amyloid beta, a substance that is associated with dementia.
During clinical trials, at least three of the 853 test patients who received donanemab died of a condition called amyloid-related imaging abnormalities (ARIA), causing the brain to bleed or swell. On the other hand, no deaths were recorded in a 874-strong placebo group.
Critics of donanemab urged the committee before the vote to not approve the drug due to the fact that some test patients died in the trials.
In particular, Georgetown University Medical Center senior research fellow Judy Butler criticized the Eli Lilly drug, urging the committee to reject the medication, saying that the acronym ARIA was a euphemism for brain hemorrhaging.
In response, Eli Lilly vice president of global patient safety Melissa Veenhuizen told the panel that there was "no evidence" of an increased risk of mortality or that there were more ARIA-related deaths due to donanemab beyond the three recorded in the trials.
Despite this, the FDA said that it was not overly alarmed by the questionable safety profile of donanemab, noting in a report that the findings were "generally consistent" with the class of drugs aiming to reduce or eliminate amyloid plaques.
After the hearing, the committee unanimously voted that donanemab was effective and its benefits outweigh the risks for patients with mild dementia as well as mild cognitive impairment.
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Caveats for Donanemab
While it was a unanimous decision, some committee members stressed that their affirmative vote was conditional, saying that the importance of educating healthcare providers and patients is still paramount.
In particular, the FDA panel's consumer representative, Sarah Dean, said that people should "think responsibly" in the event that donanemab would be released to the market due to the risks that it entailed during the trials.
Reuters reported that while the committee's favorable recommendation was not binding on the FDA, it would allow Eli Lilly to win regulatory approval. In the event donanemab gets FDA approval, it would be the third anti-amyloid drug to achieve such a nod since 2021, after Biogen's Aduhelm and Eisai's Leqembi.
However, CNBC reported that both drugs have since been discontinued due to the FDA's hasty approval process despite its advisory panel's negative recommendation.
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