Eli Lilly’s Alzheimer’s Treatment Kisunla Secures Fourth Major Market Approval with NMPA Authorization in China

Eli Lilly and Company has secured approval from China’s National Medical Products Administration (NMPA) for Kisunla, its Alzheimer’s treatment. This follows this year’s earlier approvals in the United States, Japan, and Great Britain, expanding the drug’s global reach. With a market capitalization exceeding $700 billion and gross profit margins of nearly 81%, the company maintains a strong financial position, supporting its continued growth.

Alzheimer’s Prevalence in China Projected to Reach 11% by 2050 

Alzheimer’s disease affects nearly 6% of China’s population aged 65 and older, with projections indicating this figure could rise to 11% by 2050. The recent approval of Kisunla introduces a new therapeutic option for managing the condition by targeting amyloid plaque buildup in the brain. 

“Bringing Alzheimer’s disease treatment options to the people facing its devastating effects is critical. Patients and their families want and deserve access to treatment with amyloid targeting therapies, which could give them more time to do the things that matter most to them in the early symptomatic stage of the disease,” said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company.

The NMPA’s approval of Kisunla is based on the results of the TRAILBLAZER-ALZ 2 Phase 3 clinical study. This trial showed that Kisunla significantly slowed the progression of Alzheimer’s disease, particularly in patients with less advanced stages. Participants experienced a 35% slower decline in cognitive and daily functioning compared to those on a placebo, and the treatment reduced amyloid plaques by up to 84% over 18 months, with 66% of patients clearing plaques within one year.

Ilya Yuffa added, “Kisunla continues to demonstrate very meaningful results for people with early symptomatic Alzheimer’s disease and can now help to improve the standard of care for people living with the disease in China.”

Kisunla Reduces Amyloid Plaques by Up to 84% with Evidence for Treatment Cessation

Amyloid is a naturally occurring protein in the body that can accumulate to form amyloid plaques. Kisunla targets and removes these plaques, which are associated with memory and cognitive issues in Alzheimer’s disease. Other amyloid plaque-targeting therapies, such as Biogen’s Aduhelm (aducanumab) and Eisai’s Lecanemab (LEQEMBI), also focus on reducing amyloid plaques in the brain. However, Kisunla is the only therapy that supports stopping treatment once plaques are cleared, which is projected to reduce treatment costs and eliminate the need for ongoing infusions.

While Kisunla shows promise in treating Alzheimer’s, it may cause side effects, including amyloid-related imaging abnormalities (ARIA), such as temporary brain swelling or bleeding, and infusion-related reactions. Doctors can monitor and manage ARIA through MRI scans, even though it often occurs without symptoms.

Despite these side effects, Eli Lilly has reported a 27% increase in revenue over the past 12 months and continues to project strong earnings growth, signaling its continued expansion in the market.

Author

Denisse Sandoval