The Food and Drug Administration's (FDA) advisory committee endorsed Monday (June 10) Eli Lilly's Alzheimer's drug, donanemab, for approval to further slow the aggression of the specific type of dementia in patients.
The Washington Post reported that the drug was not able to cure or halt the condition, but it could slow the cognitive and functional decline in people in the early stages of the disease by 35% over 18 months.
Eli Lilly vice president Mark Mintun said in a statement that they were "pleased" with the committee's approval and were looking forward to becoming a treatment option to patients.
According to Wall Street analysts, the company's shares also rose 1.8% Monday while the panel members voted in favor of the drug.
However, Leerink Partners analyst David Risinger said in a research note on Sunday (June 9) that the drug has 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 called amyloid beta from the brain, a substance associated with dementia.
During clinical trials, at least three test patients of the 853 who received the drug died of a condition called amyloid-related imaging abnormalities (ARIA), which could cause the brain to bleed or swell, while no deaths were recorded in a placebo group, which numbered 874.
Critics of donanemab urged the committee before the vote to not approve the drug because some test patients died in the trials.
One of the more vocal critics was Georgetown University Medical Center senior research fellow Judy Butler, who urged 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 excess deaths related to the drug beyond the three deaths associated with ARIA.
Despite this, the FDA said that it was not overly alarmed by donanemab's questionable safety profile, noting in a report that the findings were "generally consistent" with the class of drugs aiming to reduce or eliminate amyloid plaques.
In conclusion of the report, the committee voted unanimously, 11-0, that donanemab was effective and its benefits outweigh the risks for patients with mild dementia as well as mild cognitive impairment.
Caveats for Donanemab
While it was a unanimous decision, some committee members stressed that their affirmative vote was conditional, saying that educating healthcare providers and patients is still paramount.
In particular, the FDA panel's consumer representative, Sarah Dean, said that people should "think responsibly" about whether donanemab would be released to the market due to the risks 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. If 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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