FDA Nods to Donanemab: Memory Lane Just Got a Service Road

FDA Nods to Donanemab: Memory Lane Just Got a Service Road

3 minute read
Published: 7/3/2024

In a move signaling hope for Alzheimer's patients, the FDA approved Eli Lilly’s drug Kisunla, which promises to slow cognitive decline, provided you don’t mind the occasional brain swelling or bleeding.

The FDA's green light for Kisunla, an amyloid plaque-busting drug tailored for those in the early stages of Alzheimer's, is seen as a promising step forward—assuming you're okay with the minor side effect of potential brain swelling or bleeding. Administered via monthly IV infusions, Kisunla aims to slow down the relentless march of cognitive decline, making it the third such drug to be approved since 2021. While the treatment isn't exactly a bargain, ranging from $12,522 to $48,696 depending on the duration, Eli Lilly promises a less frequent infusion schedule and quicker sessions compared to its predecessors. So folks, weigh your options: cling to a few more memories or risk the occasional cerebral storm.

The decision follows the unanimous recommendation from an FDA advisory committee, which had promptly reviewed the data and given Kisunla a collective thumbs up. Eli Lilly, not one to waste time, has promised that Kisunla will hit the market within weeks—just in time for summer reading lists you may actually remember finishing.

Kisunla is specifically approved for adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia. By targeting amyloid plaques in the brain, the drug's goal is to slow cognitive and functional decline, which trials show it does by approximately 22% compared to a placebo group. It's not quite like hitting the pause button on memory loss, but it’s a start.

Patients receiving Kisunla will be treated with a monthly intravenous (IV) infusion, a process Eli Lilly proudly points out is shorter and less frequent than other treatments in the same category. So, if you’ve already got a full schedule of things you don’t want to forget, you can at least pencil in fewer and briefer Kisunla sessions.

Of course, no treatment is without its risks. Potential side effects include brain swelling, brain bleeding, and other issues with brain function; in other words, buy enough post-it notes and band-aids just in case. On the brighter side, nearly half of the patients in the clinical trials were able to discontinue the treatment after their amyloid plaques had been cleared, offering some hope that maybe you can have your memory cake and eat it too.

Since 2021, two amyloid-clearing Alzheimer’s drugs have already been approved: Leqembi (lecanemab) and Aduhelm (aducanumab). Kisunla now joins the lineup, entering a ring where pharmaceutical giants attribute varying success to their own memory savers. What sets Kisunla apart is not just the less taxing infusion schedule but its economic proposition—or lack thereof. Treatment costs range from $12,522 for a six-month period to a steep $48,696 for 18 months, leaving balance sheets weeping while brains breathe a cautious sigh of relief.

The FDA had originally scheduled an advisory committee meeting to review more detailed safety and effectiveness data before giving Kisunla the nod. Clearly, the advisors liked what they saw. Considering the stakes, who can blame them? There’s nothing quite like the promise of remembering your own grandchildren's names to tip the scales in favor of a quicker approval process.

Eli Lilly’s announcement that Kisunla will be available within weeks adds a timely option for patients grappling with early Alzheimer’s. While it’s not a cure, this newly approved drug does offer a viable tool for slowing down the decline, provided patients can manage the side effects and, well, the cost. As always, the balance between benefit and risk will be crucial. In the meantime, though, the message is simple: Alzheimer's patients, prepare for some aid on your journey down memory lane—but perhaps with a side of mild apprehension.