Alzheimer's Drug Donanemab Faces Second Regulatory Delay Amid Ongoing Safety and Efficacy Scrutiny

　　【Pharmaceutical Network Product Information】Alzheimer's disease, commonly known as "senile dementia," is mainly characterized by dementia, which refers to the progressive impairment of memory, reasoning, and social functions. This ultimately leads to the complete loss of patients' ability to learn, remember, and live independently, requiring full-time care and companionship, bringing immense pain and burden to families. In recent years, with the intensification of population aging, the number of Alzheimer's patients has been increasing, driving the growth of the related market. Data shows that the size of China’s Alzheimer's disease diagnosis market was approximately 21.75 billion yuan in 2020 and is expected to reach 26.02 billion yuan by 2025.
 

Facing a considerable market space, pharmaceutical companies in and outside of China have already made their moves. However, the launch of new drugs is not an easy task, and many pharmaceutical companies have encountered setbacks during this period.
 

March 8 news: The U.S. FDA has decided to delay the approval of Eli Lilly's donanemab drug and will organize a related meeting to discuss the drug’s safety and efficacy.
 

It is reported that this is the second time Donanemab has been delayed in approval by regulatory authorities, indicating its challenging path to market.
 

Donanemab is a monoclonal antibody that binds to the N3pG subtype of amyloid-beta protein, capable of binding to amyloid-beta protein deposits in the brains of Alzheimer's disease patients, thereby promoting the clearance of amyloid plaques in the patient’s brain.
 

Previously, in 2023, Eli Lilly had released the clinical trial data of this drug. The results showed that donanemab demonstrated a certain level of efficacy in slowing the decline of memory and cognitive abilities, with an overall reduction ranging between 22% and 29%. This is comparable to the 27% reduction in decline shown by Leqembi, a drug jointly developed by Biogen and Eisai.
 

In China, Leqembi was approved for use in January 2024 and is expected to be launched in the Chinese market in the second half of this year.
 

Regarding the recent delay in approval by regulatory authorities once again, Eli Lilly stated that the U.S. Food and Drug Administration (FDA) has notified Eli Lilly and Company, expressing the desire to further understand and evaluate topics related to the safety and efficacy of donanemab, including safety outcomes in patients treated with donanemab.
 

In addition to Eli Lilly, Johnson & Johnson, Roche, and Merck have also faced setbacks in the field of Alzheimer's disease drug treatment.
 

In June 2022, Roche and the Banner Alzheimer's Institute jointly announced that the Phase II clinical trial of crenezumab for autosomal dominant Alzheimer's disease (AD) had failed.
 

In 2018, Pfizer announced the discontinuation of the development of new Alzheimer's drugs, citing high research and development costs and poor efficacy as the reasons.
 

In 2017, Merck announced the termination of the Phase III clinical trial of the Alzheimer's drug Verubecestat, stating that it was almost impossible to achieve positive clinical results.
 

In July 2016, TauRx, a Singapore-based biotechnology company, announced that its Alzheimer's drug LMTX had failed due to the Phase III clinical trial not improving patients' cognitive function.
 

According to a previous report by the Pharmaceutical Research and Manufacturers of America, between 1998 and 2017, a total of 146 Alzheimer's disease drugs failed during clinical trials worldwide, with only four drugs targeting disease symptoms being approved for marketing. Moreover, in the past 20 years, the number of new Alzheimer's drugs globally has remained limited.
 

From the perspective of the domestic progress in the launch of anti-dementia drugs, on January 9, the website of the National Medical Products Administration (NMPA) showed that the marketing application for lecanemab injection, a novel Class 1 drug submitted by Eisai, has been officially approved. Lecanemab is an anti-amyloid-beta (Aβ) protofibril antibody, and its approved indication is for the treatment of early Alzheimer's disease (AD), specifically mild cognitive impairment (MCI) due to AD with confirmed amyloid pathology and mild AD dementia. Prior to the approval of this drug, medications used in China for treating Alzheimer’s disease included sodium oligomannate capsules (brand name: GV-971) from Green Valley Pharmaceuticals, cholinesterase inhibitors, and others.
 

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