Recently, the U.S. FDA approved the marketing of lecanemab-irmb subcutaneous injection (U.S. trade name: LEQEMBI IQLIK™), jointly developed by Biogen and Eisai, for the maintenance treatment of early Alzheimer's disease (AD).

It is worth mentioning that this injection is the first Alzheimer's disease treatment drug that patients can inject themselves at home. The entire injection process takes only 15 seconds, compared to the traditional intravenous injection of 1 hour, which greatly shortens the time and improves efficiency, freeing patients from tedious hospital treatment and enjoying a more free and flexible treatment experience.

The price of this subcutaneous injection has not been released yet, but referring to the price of its intravenous formulation, lencanicarbozumab, the annual treatment cost of the intravenous formulation of lencanicarbozumab is approximately US$26,500 (approximately RMB 190,000) in the United States; and approximately RMB 180,000 per year in China.

01 Achieve home treatment

According to data, Lecanemab was approved by the FDA in 2023, becoming the first Alzheimer's disease treatment drug to be fully approved by the FDA in nearly 20 years, marking a new stage in AD treatment.

Lencanerzumab can bind to β-amyloid oligomers, a substance that accumulates abnormally in the brains of Alzheimer's patients, promoting the clearance of β-amyloid in the patient's brain and reducing further accumulation of plaques, thereby changing the disease pathology and alleviating disease progression.

However, intravenous infusions have many limitations, such as requiring patients to frequently travel to the hospital and requiring lengthy infusions. The recent launch of the subcutaneous autoinjection formulation of lencanelumab has revolutionized this landscape. Its unique injection method offers unprecedented convenience for patients and opens a new chapter in home treatment.

The biggest advantage of subcutaneous injection over traditional intravenous injection is its convenience. Patients or caregivers can administer the injection themselves at home, and the entire process takes only about 15 seconds. This not only significantly reduces the number of trips and time costs for patients, but also significantly improves treatment compliance.

Traditional intravenous infusions require patients to regularly visit hospitals or specialized medical facilities, with each infusion lasting approximately an hour. This is not only time-consuming for patients and their families, but can also increase the risk of infection. The introduction of subcutaneous autoinjectable formulations allows patients to receive treatment in the familiar environment of their own home, avoiding the stress and inconvenience of a hospital setting.

It is worth mentioning that the subcutaneous injection dosage form approved this time is not for initial treatment, but for maintenance treatment. Patients need to receive an initial treatment of 10 mg/kg intravenously once every two weeks for 18 months before they can choose to switch to a 360 mg subcutaneous injection once a week.

lecanemab-irmb subcutaneous injection

Image source: Saiwei Bio

In terms of efficacy, the efficacy of the subcutaneous injection formulation has been verified in multiple clinical trials.

Based on data from the Phase III Clarity AD clinical trial and its open-label extension study, subcutaneous administration is as effective as intravenous administration in reducing cognitive decline. After 18 months of treatment, patients receiving subcutaneous administration achieved a mean change of -0.45 on the Clinical Dementia Rating Scale-Sum (CDR-SB) score, a result consistent with that seen in the intravenous group, indicating that subcutaneous administration can effectively slow cognitive decline in patients.

The subcutaneous formulation of lecanemab also demonstrates significant safety advantages. Compared to intravenous administration, the incidence of systemic reactions with subcutaneous injection is less than 1%, significantly lower than the 26% seen with intravenous administration. Approximately 11% of patients may experience mild to moderate local reactions, such as redness, swelling, or itching at the injection site, but these reactions generally do not affect continued treatment.

From a market perspective, the launch of its subcutaneous injection formulation will further expand Lencaneluzumab's market share. Yaozhi data indicates that Lencaneluzumab (intravenous) sales will reach 2.1 billion yuan in 2024, the first full calendar year after its launch, demonstrating rapid growth.

Lencaneluzumab's price varies slightly across different regions. In the United States, the annual cost of intravenous administration is approximately US$26,500 (approximately RMB 190,000). In China, the price of Lencaneluzumab is RMB 2,508 per 200 mg (2 mL) vial. For a 60 kg patient, the annual cost is approximately RMB 180,000.

02 Continuous R&D progress

In recent years, significant progress has been made in the treatment of Alzheimer's disease, with a number of new drugs being launched or entering the late stages of research and development, bringing new hope to patients.

In terms of marketed drugs, the Alzheimer's disease drugs currently on the market cover a variety of mechanisms of action and therapeutic targets, ranging from symptomatic treatment to disease-modifying treatment, providing diverse treatment options for patients at different stages.

Donepezil hydrochloride

Developed by Corium International Inc., it was approved in March 2022. As an acetylcholinesterase inhibitor, donepezil hydrochloride improves cognitive function by increasing the level of acetylcholine in the brain and is mainly used to treat patients with mild to moderate Alzheimer's disease.

Aducanumab

Jointly developed by Neurimmune AG and Biogen, adulumab was approved in June 2021. As the first approved disease-modifying therapy for Alzheimer's disease, it reduces the accumulation of beta-amyloid protein in the brain. Although its clinical efficacy remains controversial, its launch remains significant, providing valuable insights for subsequent research and development.

Rivastigmine

Developed by Luye Pharma Group Co., Ltd., it was approved in March 2013. As an acetylcholinesterase inhibitor, rivastigmine improves cognitive function by increasing acetylcholine levels in the brain. It is primarily used to treat patients with mild to moderate Alzheimer's disease and is widely used clinically.

In terms of drugs under development, Changchun Huayang's succinate (an innovative drug), Anavex Life Sciences Corp's bremasen (an innovative drug), and Lipin Pharmaceutical's donepezil hydrochloride (an improved new drug) have made the fastest progress and have entered the registration application stage (see the figure below for details).

03 Thinking about Dilemma

Alzheimer's disease (AD) is one of the most common neurodegenerative diseases worldwide, causing great impact on patients and their families.

The global prevalence of Alzheimer's disease is substantial and continues to grow. According to the World Health Organization (WHO), in 2021, there were approximately 57 million people with dementia worldwide, of whom 60%-70% were diagnosed with Alzheimer's disease.

WHO releases data on dementia and AD patients

Image source: WHO

Alzheimer's disease not only affects patients' cognitive function and ability to perform daily activities, but also places a heavy economic burden on society and patients. In 2019, the global economic cost of dementia reached US$1.3 trillion, of which approximately 50% came from the care costs of informal caregivers (such as family and close friends).

At present, high R&D costs are one of the main reasons for the high price of drugs. The development of drugs for the treatment of Alzheimer's disease requires a lot of money, time and manpower. From basic research to clinical trials to drug marketing, the process is long and costly. The global cumulative R&D investment in this field has exceeded US$600 billion, but the failure rate is as high as over 99%.

In addition, some drugs already on the market have limited effects and can only relieve symptoms or delay disease progression, but cannot fundamentally change the condition. Patients need to take medication for a long time, resulting in the continuous accumulation of treatment costs. For example, the annual treatment cost of some innovative drugs is as high as hundreds of thousands, which is a heavy burden for many families.

In addressing the challenges of Alzheimer's disease, developing effective and affordable treatments is a crucial mission for researchers worldwide. For example, continuous exploration of new therapeutic targets, optimization of drug development processes, and innovative research methods are crucial to reducing R&D costs and increasing drug accessibility and affordability. Furthermore, strengthening international collaboration, sharing scientific research findings, and promoting academic exchange will also help accelerate the R&D process.

04 Conclusion

As the global population ages, the incidence of Alzheimer's disease (AD) continues to rise, becoming a major global public health issue that demands urgent attention. Against this backdrop, the Alzheimer's disease drug market is experiencing robust growth. We look forward to seeing more exciting breakthroughs through in-depth exploration of disease mechanisms, accelerated launch of innovative drugs, and deepening global collaboration.

Source: https://news.yaozh.com/archive/46029.html