After more than half a year of delay from the initial expected approval time, Lilly's Alzheimer's disease treatment drugs have finally been approved in the United States.
On July 2nd local time, Eli Lilly announced that the US Food and Drug Administration (FDA) has approved Kisunla (commonly known as Donanemab) for the treatment of early symptomatic adult Alzheimer's disease (AD) patients, including those with mild cognitive impairment and those in the mild dementia stage of neurodegenerative diseases.
Lilly initially expected Donanemab to be approved by the end of 2023, but the actual approval time has been pushed back and forth. This approval makes Donanemab the second drug in the US market aimed at slowing down the progression of Alzheimer's disease. Lilly stated that this drug is also the first anti amyloid protein drug that can stop treatment after removing amyloid plaques, reducing the number of infusions and lowering treatment costs.
In the global pharmaceutical industry, many pharmaceutical companies are increasing their research and development of Alzheimer's disease drugs, but the results are not ideal. According to data from the American Association for Drug Production and Development, the global cumulative R&D investment in Alzheimer's disease exceeds 600 billion US dollars, with over 300 failed clinical drugs and a failure rate of 99.6%. Therefore, Alzheimer's disease drugs are also known as the "R&D black hole".
With more and more new drugs being approved, the pharmaceutical industry is emerging from the "death valley" of Alzheimer's disease research and development, and competition in the field of Alzheimer's disease is also on the verge of breaking out.
Alzheimer's disease (AD) is known as the "eraser in the brain", and patients' thinking, memory, and independence are impaired, not only affecting their quality of life, but even leading to death. In July 2023, Japanese pharmaceutical company Eisai's lenkanizumab was fully approved in the United States for the treatment of Alzheimer's disease, becoming the first AD drug in 20 years to receive full FDA approval, while Eli Lilly's Kisumla is the second drug in the US market aimed at slowing down the progression of Alzheimer's disease.
Abnormal deposition of beta amyloid protein (A β) is one of the widely recognized mechanisms of Alzheimer's disease in the industry. Lilly's Donanemab and Eisai's lencamab are both anti amyloid beta (A β) drugs.
The approval of Eisai's lencamab is based on phase III data from a large-scale global Clarity AD clinical trial. The main endpoint of this experiment is the Global Cognitive and Functional Scale, also known as CDR-SB. Compared to placebo, lencamab treatment reduced the clinical decrease in CDR-SB by 27% at 18 months.
Lilly's approval this time is based on the results of the TRAILBLAZER-ALZ 2 experiment. According to research data disclosed by Lilly in July 2023, among participants with mild cognitive impairment, donanemab slowed decline by 60% on the iADRS (Alzheimer's Disease Comprehensive Rating Scale) and CDR-SB by 46%.
In addition to different research data, the frequency and price of medication for the two drugs are also different: lencamab needs to be administered every two weeks, and Donanemab needs to be administered every four weeks. The unit price of Eli Lilly's Alzheimer's disease medication is more expensive, reaching $695.65 per bottle, with an annual treatment cost of $32000, while the treatment cost of lencamab in the United States is about $26500. However, Lilly emphasizes that Donanemab can stop treatment after removing amyloid plaques, and the actual total cost of treatment for patients will depend on when they complete the treatment.
In January of this year, lencamab was approved in China. On June 28th, Weicai China announced that the drug has officially been launched in China. According to public information, the drug has not yet been included in medical insurance, and the patient's self funded annual treatment cost is about 180000 yuan. If calculated based on the clinical trial of completing one treatment cycle in 18 months, the total treatment cost for one and a half years is around 270000 to 300000 yuan.
When is Donanemab expected to arrive in China after being approved in the United States? Currently, Lilly China has not disclosed any relevant information. Many domestic pharmaceutical companies are also expanding their research and development of Alzheimer's disease drugs, mostly in the early stages. According to a research report from Galaxy Securities, there are a total of 34 new clinical AD drugs in China, involving listed pharmaceutical companies such as Hengrui Pharmaceutical (600276), Xiansheng Pharmaceutical (2096. HK), and Tonghua Jinma (000766).