On October 31, according to the official website of CDE, Lilly's new AD drug Donanemab
was declared on the market domestically (Acceptance No.: JXSS2300082).
Following the receipt of a CRL from the U.S. FDA in early FY23, Lilly has resubmitted a New Drug Listing Application (BLA) for Donanemab to the FDA in Q2 based on the positive results of the Phase III study of TRAILBLAZER-ALZ 2, and expects to receive a response by the end of the year. Outside of the U.S., Lilly also plans to file marketing applications for the drug in other markets around the world, most of which will also be completed by the end of the year.
In July, Lilly presented complete results from the Phase III clinical trial TRAILBLAZER-ALZ 2 of the Aβ monoclonal antibody Donanemab at the Alzheimer's Association International Conference (AAIC).
The TRAILBLAZER-ALZ 2 study (Registry No. NCT04437511) is a randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Donanemab in patients with early symptomatic Alzheimer's disease. Participants were stratified according to subjects' levels of tau protein, a predictive biomarker of Alzheimer's disease progression.
As previously reported, in subjects with low to moderate tau levels (n=1182), the primary endpoint, iADRS, showed that Donanemab delayed cognitive decline by up to 35% (p<0.0001), and another important key metric, the CDR-SB score, showed that Donanemab delayed patients' cognitive decline by 36% after 18 months (p<0.0001); in all subjects with Alzheimer's disease, the primary endpoint was iADRS. 0.0001); in all subjects (n=1736), the decline was 22% and 29%, respectively.More detailed data presented at the AAIC showed that Donanemab provided cognitive and functional benefits compared to placebo, regardless of baseline disease and stage of pathology.
The TRAILBLAZER-ALZ 2 study included patients with deeper disease states than other similar drugs, meaning that the corresponding patient population was broader.
In addition, a predefined subgroup analysis of subjects with low levels of tau protein, based on clinical stage, showed that Donanemab had a greater benefit in patients in the early stages of the disease:
In subjects with mild cognitive impairment (n=214), Donanemab slowed the decline of iADRS by 60% and CDR-SB by 46%. In patients with mild dementia of Alzheimer's disease origin (n=534), Donanemab slowed the decline in iADRS and CDR-SB by 30% and 38%, respectively.
Similarly, a post hoc subgroup analysis of subjects with low to moderate levels of tau protein based on age showed that donanemab had a greater benefit in patients under 75 years of age:
In subjects under 75 years of age (n=542), donanemab slowed the decline in iADRS by 48% and the decline in CDR-SB by 45%.
In subjects aged 75 years or older (n=551), donanemab slowed the decline in iADRS by 25% and CDR-SB by 29%.
Results were similar in all other subgroups analyzed, including subjects carrying or not carrying the ApoE4 allele.
Overall treatment effects for donanemab continued to increase throughout the trial compared to placebo, with the largest difference occurring at 18 months.
Domestically, according to the Insight database, donanemab was first declared in the clinic in April 2022, first approved for the clinic in June, initiated in the clinic in August and was declared for marketing today.