FDA approves second anti-amyloid beta antibody for Alzheimer’s

Neurons in a brain with Alzheimer's disease

Eli Lilly’s anti-amyloid beta monoclonal antibody (mAb) Kisunla (donanemab) has become the second disease-modifying therapy for Alzheimer’s disease (AD) to reach the US market, following approval by the US Food and Drug Administration (FDA).

It has been approved by the regulator for the treatment of patients with mild cognitive impairment (MCI) or mild AD with confirmed amyloid pathology, after initial delays in the approval process.

The decision was based on Phase III trial data which showed Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.

In addition, once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study.

“Kisunla demonstrated very meaningful results for people with early symptomatic AD, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, Executive Vice President and President of Lilly Neuroscience, Eli Lilly.

Amyloid plaque removal

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with AD.

One of the treatment goals of the TRAILBLAZER-ALZ 2 study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography (PET). If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study.

“This approval marks another step forward in evolving the standard of care for people living with AD that will ultimately include an arsenal of novel treatments, providing much needed hope to the AD community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF).

The FDA cautions that Kisunla can cause amyloid-related imaging abnormalities (ARIA), which may present as temporary swelling in an area or areas of the brain, which usually resolves over time. However, in some cases, ARIA can be serious, and life-threatening events can occur.

Once-monthly dosing schedule

Eisai and Biogen’s Leqembi (lecanemab), another disease-modifying anti-amyloid beta (Aβ) monoclonal antibody (mAb) for AD, received full FDA approval in July 2023, though questions have been raised over how effective it is.

Philippa Salter, Managing Neurology Analyst at GlobalData, commented: “An important competitive advantage for Kisunla is its once-monthly dosing schedule compared with Leqembi’s dosing of once every two weeks. Further, despite having a higher annual cost of therapy of $32,000 for Kisunla compared with $26,500 per year for Leqembi, Lilly states that in the long term, Kisunla will be cheaper and more convenient for patients since they won’t have to take the drug indefinitely.

“While there are clear advantages in not having to take a drug indefinitely, many questions have been raised about what happens once donanemab therapy is stopped. Further real-world evidence and clinical trial data will be key for physicians to feel confident in stopping treatment with Kisunla and therefore vital for the success of the drug.”

Diana Spencer, Senior Digital Content Editor, DDW

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