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Global medicine company Eli Lilly has announced that the National Medical Products Administration (NMPA) of China has approved its brand of donanemab-azbt (Kisunla), a monoclonal antibody used in adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment (MCI) and those in the mild dementia stage of the disease with confirmed amyloid pathology.

Donanemab is an amyloid plaque-targeting medication that can assist the body in eliminating the excessive accumulation of amyloid plaques in the brain, which can cause Alzheimer's disease-related memory and cognitive problems.

This therapy can help slow down deterioration that could impair a person's capacity to plan and organize, prepare meals, use home appliances, handle finances, remember new information, significant dates, and appointments.

As the only amyloid plaque-targeting medication with data to support terminating treatment once amyloid plaques are eliminated, donanemab may save treatment expenses and need fewer infusions.

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Following the United States, Japan, and Great Britain, China becomes the fourth country to approve Kisunla for use in the management of the disease.

The approval is based on results from a Phase 3 study coded TRAILBLAZER-ALZ 2, which demonstrated that among participants treated with Kisunla who were less advanced in their disease, there was significant slowing of decline of 35% compared with placebo in measures such as memory, thinking, and daily functioning.

In the overall population, the response to treatment was also statistically significant at 22%.

In comparison to the beginning of the trial, Kisunla decreased amyloid plaques in the general participant population by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months.

Reducing amyloid plaques to levels that would result in a visibly negative amyloid positron emission tomography (PET) scan was one of the study's treatment objectives.

Participants could finish Kisunla medication and transition to a placebo for the balance of the study if it was verified that they had attained these levels.

According to the aforementioned criteria, 66% of participants in the TRAILBLAZER-ALZ 2 study achieved plaque clearance after a year.

"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. "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."

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