Expert available: FDA approval of Alzheimer’s disease drug, donanemab

The FDA approved a new Alzheimer’s disease treatment today called donanemab (brand name Kisunla), after it was reviewed and recommended by an advisory panel earlier this year.

Sanjeev Vaishnavi, MD, PhD, an assistant professor of neurology at Penn Medicine, is the Principal Investigator of the TRAILBLAZER trial of the drug at Penn Medicine, and has extensive expertise working with patients who have Alzheimer’s disease in the Penn Memory Center, and is available to discuss donamemab, how the drug works, and what this approval means for patients and families.

As one of the first sites to establish the infrastructure to administer lecanemab (Lequembi), an AD drug approved last summer, Penn is particularly well-position to be able to advise patients on the new therapy, and deliver it to those it would benefit.

ABOUT DONANEMAB

• Donanemab is an antibody infusion that helps the patient’s body remove amyloid plaque buildup on the brain, which causes symptoms of Alzheimer’s disease;
• Penn Medicine was a site for the TRAILBLAZER trial, and Dr. Vaishnavi was the principal investigator;
• Donanemab infusions take place every four weeks, while Leqembi infusions take place every two weeks;
• Individuals in the trial received a PET scan at 24 and 52 weeks – if the scan showed beta-amyloid plaque had cleared, the patient could stop treatment;
• A number of patients were able to stop infusions in less than a year – Leqembi has no such endpoints;
• Individuals treated with donanemab showed a slowing in the progression of AD symptoms, like cognitive decline. The trial found that patients in earlier stages of AD showed more benefit from the drug.
• Results of the trial showed that donanemab clears amyloid more quickly than Leqembi;
• Side effects include brain swelling and bleeding, similar to other existing drugs for neurodegenerative disease, and the vast majority of side effects are reversible.