Eli Lilly's Donanemab Injection Approved for Market, New Breakthrough in Alzheimer's Treatment

On December 18, Eli Lilly announced that its developed Donanemab injection has received approval from the drug regulatory authority and is officially on the market. This medication is approved for treating adults with mild cognitive impairment and mild dementia due to Alzheimer's disease.

Eli Lilly revealed on its official Weibo account that Donanemab injection is currently the only clinically supported targeted amyloid therapy that can cease medication after clearing amyloid plaques. This therapy helps alleviate the treatment burden on patients by reducing the frequency of infusions and lowering treatment costs.

The approval from the drug regulatory authority is primarily based on data from the Phase III TRAILBLAZER-ALZ 2 clinical study (NCT04437511). This study aimed to evaluate the safety and efficacy of Donanemab injection in patients with early symptomatic Alzheimer's disease, particularly those with confirmed Alzheimer's neuropathological changes. The trial combined cognitive assessments with pathological evidence of Alzheimer's and enrolled 1,736 subjects from eight countries.

Results from the TRAILBLAZER-ALZ 2 study indicated that the effects of Donanemab injection are more pronounced in patients at earlier stages of the disease. During the 18-month trial period, subjects were divided into two groups for analysis: one group consisted of patients in the earlier stages of the disease (with low to moderate levels of tau protein), while the other group included the overall population, comprising subjects with low, moderate, and high tau levels.

The study demonstrated that treatment with Donanemab injection significantly slows clinical decline in both groups. In the population with earlier disease progression, patients treated with Donanemab injection experienced a 35% slower decline in memory, thinking, and daily functioning, as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), compared to those receiving a placebo. In the overall population, treatment significantly slowed clinical decline by 22%. Among both groups, subjects treated with Donanemab injection exhibited up to a 39% reduced risk of progressing to the next clinical stage compared to those receiving a placebo.