FDA Analysis Finds No Major Red Flags for Eli Lilly’s Alzheimer’s Drug Donanemab
In a recent evaluation of Eli Lilly’s experimental Alzheimer’s drug, donanemab, the U.S. Food and Drug Administration (FDA) staff did not identify any significant safety issues but did highlight potential risks for patients with early-stage Alzheimer’s. The findings, published on Thursday, set the stage for an upcoming advisory panel meeting that will decide whether the benefits of donanemab outweigh its risks.
Rivalry in Alzheimer’s Treatment
Donanemab is poised to compete with Eisai and Biogen’s Leqembi, which received approval last July. Both treatments target beta-amyloid plaques in the brain, a hallmark of Alzheimer’s disease, aiming to slow its progression. The FDA advisory panel will review the staff’s analysis and provide a non-binding recommendation on the drug’s approval.
Potential Approval and Safety Concerns
Should donanemab gain approval, the FDA has indicated that its prescribing label will likely include warnings about potential risks, such as brain swelling and bleeding. These side effects are particularly prevalent in individuals with two copies of the ApoE4 gene. Additional post-approval requirements may involve expedited reporting of deaths and the establishment of a patient registry to monitor side effects.
Analysts’ Expectations and Clinical Trial Results
Despite some safety concerns, analysts believe donanemab is on track for approval. In clinical trials, donanemab, administered via monthly infusions, demonstrated a 29% reduction in the progression of cognitive decline, closely matching the 27% reduction observed with Leqembi.
RBC analyst Brian Abrahams noted that while Leqembi might have a slight edge due to fewer adverse effects, the FDA’s commentary suggests a favorable stance towards approving donanemab. The trial data revealed that brain swelling occurred in 24% of participants, with brain bleeding in 31%. Most cases were mild, but serious instances were noted in 1.5% (brain swelling) and 0.4% (brain bleeding) of participants.
Comparative Analysis with Leqembi
In comparison, Leqembi’s trial showed brain swelling in 12.6% and brain bleeding in 17.3% of participants. Following Leqembi’s approval, the FDA issued a strong warning about these risks and recommended routine MRI scans to monitor patients.
Stifel analyst Paul Matteis pointed out that the labeling for donanemab might differ, particularly regarding the duration for which MRI scans are recommended.
Tau Imaging and Treatment Duration
Lilly’s study uniquely included measurements of tau protein, another indicator of Alzheimer’s progression. The company argued that tau imaging should not be necessary to determine eligibility for donanemab. In the trial, participants could discontinue treatment once brain scans confirmed the removal of amyloid plaques. However, FDA staff questioned the duration of the treatment’s benefits after cessation.
Impact on Alzheimer’s Treatment Landscape
The potential approval of donanemab marks a significant step forward in Alzheimer’s treatment. For decades, researchers have struggled to develop effective therapies for the disease, which affects over 6 million Americans, according to the Alzheimer’s Association.
Eli Lilly’s advancements, along with those of Eisai and Biogen, herald a new era of treatments designed to slow the progression of Alzheimer’s. As the FDA advisory panel prepares to meet, the decision on donanemab will be closely watched by the medical community and patients alike, offering hope for improved management of this devastating condition.
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Source: Reuters