Eli Lilly’s Alzheimer’s drug receives approval from US FDA

After facing several hurdles on its path to approval last year, Eli Lilly’s donanemab treatment for early Alzheimer’s, brand name Kisunla, received US FDA approval this past week. It is the second therapy for slowing the progression of Alzheimer’s now available to US patients. 

Earlier this year, the treatment received a recommendation from an independent advisory board despite concerns over certain adverse effects. The board was unanimously in favour of the treatment. This latest milestone for the drug product is a huge achievement for all stakeholders. “This is real progress,” commented Joanne Pike from the Alzheimer’s Assocation. “Having multiple treatment options is the kind of advancement we’ve all been waiting for – all of us who have been touched, even blindsided, by this difficult and devastating disease.” 

Donanemab works by clearing a protein called beta-amyloid from the brain, which has been shown to influence the progression of Alzheimer’s. Eli Lilly’s Kisunla differs from the already approved Leqembi from Eisai and Biogen is its finite dosing – patients do not need to continue taking the drug once brain scans are clear of amyloid plaques. However, Eli Lilly’s Kisunla is priced at US$32,000 for a 12-month course while Eisai’s is priced at US$26,500. Analysts attribute this to the non-chronic nature of the treatment compared with Leqembi. “The details of how it will play out in clinical practice are still unclear but I think it will save a lot of money and patient will like it a lot better,” stated Erik Musiek, neurologist at Barnes-Jewish Hospital. “I think that, coupled with monthly dosing, [this] will make this an attractive option.” 

A late-stage trial of donanemab demonstrated slowed progression of memory and thinking problems by 29% compared with a placebo. However, like Eisai’s Leqembi, mild brain swelling and brain bleeding were observed in a few patients. The US FDA will be placing boxed safety warnings for potential brain swelling and bleeding on Kisunla, as it has for Leqembi. While Eisai’s product only requires four MRI scans to check for side effects, Kisunla will require five. This may provide some advantage for regions where access to scans is more difficult. Kisunla is expected to be available mostly for patients enrolled in Medicare age 65 and over.  

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Eli Lilly Alzheimer’s drug approved by US FDA [Accessed July 4, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-lillys-alzheimers-drug-2024-07-02/