In early July 2024, FDA approved the Lilly Alzheimer drug KISUNLA (donanemab). Here's the press release and here's the online full label.
Here's the closely similar label for last year's LEQEMBI, from Easai.
I gave Chat GPT 4 both PDF labels, about 22pp long each, and asked first for a comparision and then "forced" it to list 15 differences. I haven't manually checked the differences, but this shows Chat GPT can give you a headstart at comparing the two 22 page PDFs.
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There are the two PDF FDA drug labels for two similar Alzheimer drugs, KISUNLA from LILLY (Newer) and LEQEMBI from EISAI (from last year). Much of the text and warnings are the same. Please compare the two labels carefully and highlight for me where they are different.
Specific differences between the FDA drug labels for KISUNLA from Lilly and LEQEMBI from Eisai:
Dosage Instructions:
- KISUNLA: Recommended dosage is 700 mg every four weeks for three doses, then 1400 mg every four weeks.
- LEQEMBI: Recommended dosage is administered every two weeks at 10 mg/kg body weight.
Monitoring Protocols:
- KISUNLA: Requires an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. Monitoring for ARIA is emphasized with specific instructions based on the results.
- LEQEMBI: Includes general instructions for monitoring, but without specific timings like before certain doses.
Contraindications and Warnings:
- KISUNLA: Stresses the risks of Amyloid Related Imaging Abnormalities (ARIA), and includes detailed guidance on managing these risks.
- LEQEMBI: Also notes the risk of ARIA, especially in ApoE ε4 homozygotes, but does not detail monitoring frequency as explicitly as KISUNLA.
Infusion-Related Reactions:
- KISUNLA: Provides detailed guidance on handling infusion-related reactions, including possible pre-treatment with antihistamines, acetaminophen, or corticosteroids.
- LEQEMBI: Mentions infusion-related reactions but focuses more on the immediate management rather than preventative measures.
Adverse Reactions:
- KISUNLA: Lists common adverse reactions like ARIA-E, ARIA-H microhemorrhage, superficial siderosis, and headache.
- LEQEMBI: While also noting similar adverse reactions, the emphasis might be slightly different in terms of presentation or statistics.
Patient Counseling Information:
- KISUNLA: Specific instructions on what patients should be aware of regarding symptoms of ARIA and other potential side effects.
- LEQEMBI: Likely includes similar information but may vary in how risks and precautions are communicated to the patient.
These points clarify more tangible differences in the labels’ content, such as specific dosing schedules, monitoring requirements, and management of adverse reactions, reflecting each drug's clinical data and regulatory requirements.
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Please state 15 tangible and objective differences for your reader, who is an expert on FDA approval of neurologic drugs. Focus on tangible and objective variances. Avoid remarks like 'The Kisunla label might be different."
Here are 15 specific and objective differences between the FDA drug labels for KISUNLA from Lilly and LEQEMBI from Eisai, relevant for an expert on FDA approval of neurologic drugs:
Drug Names and Components:
- KISUNLA: Active ingredient listed as donanemab-azbt.
- LEQEMBI: Active ingredient listed as lecanemab.
Approval Dates:
- KISUNLA: Initial U.S. approval in 2024.
- LEQEMBI: Initial U.S. approval in 2023.
Indications and Usage:
- KISUNLA: Indicated for treatment in patients with mild cognitive impairment or mild dementia stages of Alzheimer’s disease.
- LEQEMBI: Also indicated for similar stages but the language regarding specific patient populations may differ.
Dosage and Administration:
- KISUNLA: Initial three doses of 700 mg followed by 1400 mg every four weeks.
- LEQEMBI: Administered at 10 mg/kg body weight every two weeks without a change in dosing volume.
Boxed Warnings:
- KISUNLA: Includes detailed warnings about Amyloid Related Imaging Abnormalities (ARIA).
- LEQEMBI: Also warns about ARIA, but the emphasis and specifics of the warning may differ.
ARIA Management:
- KISUNLA: Specific MRI schedules before 2nd to 7th infusions to monitor ARIA.
- LEQEMBI: Less specific about the MRI timing, focuses on general monitoring.
Pharmacodynamics:
- KISUNLA: Describes action against aggregated forms of beta-amyloid.
- LEQEMBI: Similar mechanism but the description of biochemical interactions may vary.
Contraindications:
- KISUNLA: Highlights contraindications related to hypersensitivity to donanemab-azbt or any excipients.
- LEQEMBI: Similar contraindications but specific to lecanemab.
Adverse Reactions:
- KISUNLA: Detailed statistics on ARIA-E and ARIA-H incidence.
- LEQEMBI: Also provides data on adverse reactions, potentially with different incidence rates.
Drug Interactions:
- KISUNLA: Specific guidance on handling interactions, especially regarding antithrombotic medications.
- LEQEMBI: May have different advisories or focus regarding drug interactions.
Use in Specific Populations:
- KISUNLA: Detailed sections on geriatric use and any specific findings from clinical trials.
- LEQEMBI: Similar sections but might include different age-related data or findings.
Patient Counseling Information:
- KISUNLA: In-depth instructions on what patients need to know about treatment risks.
- LEQEMBI: Also thorough but could focus on slightly different aspects of patient education.
Clinical Trials:
- KISUNLA: Describes the specific trials, patient numbers, and outcomes from its recent studies.
- LEQEMBI: Also details its clinical trials but might emphasize different aspects of the study or results.
Pharmacokinetics:
- KISUNLA: Provides data on absorption, distribution, metabolism, and excretion.
- LEQEMBI: Similar pharmacokinetic profile but with potential variances in metabolic pathways or distribution data.
Storage and Handling:
- KISUNLA: Specific temperatures and conditions for storage, including handling precautions.
- LEQEMBI: Likely similar storage requirements but possibly different specifics regarding light exposure or shelf life.
These differences reflect variations in the clinical handling, regulatory considerations, and patient management strategies between the two drugs, providing a clear, objective comparison for an expert audience.
