FDA approves Lilly’s Kisunla for Alzheimer’s treatment

USA —The U.S. Food and Drug Administration (FDA) has approved Kisunla (donanemab-azbt), a groundbreaking Alzheimer’s treatment developed by Eli Lilly and Company.

This new therapy is specifically designed for adults with early symptomatic Alzheimer’s disease (AD), including individuals with mild cognitive impairment (MCI) and those in the mild dementia stage of AD, provided they have confirmed amyloid pathology.

Kisunla, administered once monthly, stands out as the first and only amyloid plaque-targeting therapy, with evidence supporting the cessation of therapy once amyloid plaques are removed.

This approach could lead to significantly lower treatment costs and fewer patient infusions.

The approval follows the successful results of the TRAILBLAZER-ALZ 2 Phase 3 study, which revealed that individuals at the earliest stages of the disease experienced the most substantial benefits from Kisunla.

Expressing her joy over this significant milestone, Anne White, Executive Vice President and President of Lilly Neuroscience at Eli Lilly and Company, extended her gratitude to the patients and their families for participating in the clinical programs.

She also thanked Lilly’s scientists and collaborators for their perseverance over decades of research.

 White emphasized that each year, an increasing number of people are at risk for Alzheimer’s disease, and the company is determined to improve their lives.

 According to White, Kisunla has demonstrated highly meaningful results for people with early symptomatic Alzheimer’s disease who urgently need effective treatment options.

She highlighted that the greatest potential benefit of these medicines is achieved when patients are treated at the earliest stages of their disease. Eli Lilly is committed to partnering with others to enhance detection and diagnosis.

In addition, Howard Fillit, M.D., Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF), remarked that this approval represents a significant advancement in evolving the standard of care for Alzheimer’s patients.

He expressed optimism about the potential to stop treatment, which could reduce out-of-pocket costs and the infusion burden for eligible patients.

Fillit added that diagnosing and treating Alzheimer’s earlier than is currently practiced has the potential to meaningfully slow disease progression, thereby granting patients invaluable time to maintain their independence longer.

On their part, Eli Lilly has announced that their Support Services for Kisunla is a free program committed to assisting patients in navigating their treatment with Kisunla.

The program offers a range of services, including coverage determination assistance, care coordination, nurse navigator support, and customized resources.

Additionally, Lilly intends to donate Kisunla to the Lilly Cares Foundation, a nonprofit organization that provides medications at no cost to qualified Americans, including some Medicare beneficiaries, who meet financial and other eligibility criteria.

 This initiative aligns with Lilly’s longstanding tradition of supporting patient access to its products through medication donations to charitable organizations.

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