FDA expert panel backs Eli Lilly’s Alzheimer’s drug donanemab

A panel of experts advising the Food and Drug Administration announced earlier this week, with a unanimous vote, that the benefits of Eli Lilly’s Alzheimer’s drug outweigh its negative impacts.

The decision of the advisory committee is not binding but is generally followed by the FDA. The agency was meant to decide on the drug earlier this year. If approved, donanemab would become Eli Lilly’s third approved therapy for Alzheimer’s.

The approval application for the drug was based on a 1,700-patient placebo-controlled trial, which observed that patients treated with donanemab experienced thinking and memory problems progressing 29% slower. The drug also slowed overall decline by 22% compared to the placebo group. This data was measured against a scale that combined two well-known scoring systems used to measure the severity of the memory-robbing disease.

This does not mean that the results are without concern. The agency has particularly asked the panel to consider the accessibility and safety of the therapy.

In the trial results submitted to the FDA to support its approval application, it was noted that patients had to prove amyloid presence and show evidence of tau presence to be eligible for participation.

Amyloid is a protein that researchers have identified as the root cause of Alzheimer’s, and tau is another protein linked to the disease.

This means that patients would have to get PET scans to determine if they can use the medicine, and these scans can be time-consuming and costly. Overall, it becomes trickier to evaluate the trial results since there is less clarity on the role tau would play in prescribing the drug if it were approved.

Cynthia Carlsson, a panelist and professor of medicine at the University of Wisconsin, said, “Inclusion of requirements for [tau testing] will further limit the number of patients who can have access to these types of medications, so it’s a nuanced situation where, on the one hand, we do need to have additional data on the no and very low tau population. On the other hand, we should not require [tau testing] for access to this medication.”

Additionally, the broader applicability of the treatment has been questioned, as all participants involved in the trial were in earlier stages of the disease and racially white.

Moreover, safety concerns for the drug in patients who are at high risk of ARIA, and the fact that participants in the study were allowed to stop the medicine once their amyloid levels fell below a certain threshold, raised concerns regarding follow-ups and dosing.

However, it cannot be ignored that trial results found that among patients with low to medium levels of tau, treatment with donanemab slowed disease progression even further. Not to mention, the decision to discontinue treatment after a certain time in patients is an approach that some panelists have considered innovative. Regarding concerns of brain bleeds and ARIA, Lilly assured that MRIs in the later part of the trial helped them better understand the situation and exercise caution.

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