The US FDA has approved the Alzheimer's drug Leqembi, which is expected to become the first of its kind to be covered by medical insurance.

On Thursday, July 6th, the U.S. Food and Drug Administration (FDA) approved Leqembi, a treatment for Alzheimer's disease developed by Japanese pharmaceutical company Weicai and U.S.-based healthcare company Bojian.

Leqembi is the first Alzheimer's disease antibody therapy to receive full FDA approval, and it is also the first of its kind expected to have broad coverage through medical insurance. Medical insurance has committed to providing coverage for Leqembi starting on the same day as FDA approval, but with some conditions attached.

Insurance coverage is a crucial step in helping elderly Americans with early-stage Alzheimer's disease afford the cost of treatment. Leqembi is priced at $26,500 per year, and without medical insurance, most patients would be unable to afford this expensive medication.

Leqembi does not cure Alzheimer's disease. In Weicai's clinical trials, this therapy slowed the decline in cognitive abilities caused by early-stage Alzheimer's disease by 27% over 18 months. This antibody medication is administered through intravenous injections twice a month and targets a type of amyloid protein associated with Alzheimer's disease.

Tanya Simuni, a member of the FDA advisory panel and a neurology professor at Northwestern University Feinberg School of Medicine, stated:

After weighing the pros and cons, Leqembi is beneficial and acceptable as a treatment option for this type of disease.

Robert Alexander, Chairman of the Banner Alzheimer's Research Committee, pointed out:

Overall, Leqembi clearly demonstrates that it is an effective treatment method. He believes that this study clearly proves the clinical benefits and that the research results are robust and compelling.

Joanna Pike, President of the Alzheimer's Association, stated that although Leqembi does not cure the disease, it will help patients in the early stages of the disease maintain more independence, enabling them to take control of their daily lives and spend more time with their families.

In a statement on Thursday, Pike said:

This allows patients to have more time to recognize their spouses and descendants. It also means that patients have more time to drive safely, manage their finances, and fully engage in hobbies and interests.

What are the risks of Leqembi?

However, this treatment carries serious risks of brain swelling and bleeding. Three patients participating in Weicai's clinical research died. FDA scientists state that it is still unclear whether Leqembi is related to these deaths.

According to the FDA, Alzheimer's disease is the most common cause of dementia in the elderly and the sixth leading cause of death in the United States.

David Knopman, a neurologist specializing in Alzheimer's disease at the Mayo Clinic in Minnesota, stated that in Weicai's trials, Leqembi clearly demonstrated benefits for patients, although he cautioned that the effectiveness of this treatment is limited.

Knopman said that properly diagnosed and informed patients should be able to decide for themselves whether to use Leqembi after weighing the pros and cons of treatment. Medical insurance plans impose conditions on how Leqembi is covered. Patients diagnosed with early-stage Alzheimer's disease who participate in medical insurance must find healthcare providers who are part of the registration system. However, this system is controversial. The Alzheimer's Association and some members of Congress are concerned that this requirement will create barriers to treatment.

There are concerns that the number of healthcare providers participating in such registration will be limited, and people in rural and underserved communities will have to travel long distances to find such providers.

The Centers for Medicare and Medicaid Services (CMS) have committed to establishing a national portal that will allow healthcare providers to easily submit the data required for patients receiving Leqembi. The agency states that the free-to-use portal will be available once the treatment is approved by the FDA.

There are also concerns that if Leqembi is widely accepted as a treatment and there is high demand for the antibodies, there may be a shortage of specialized doctors and locations for infusions. Some studies estimate that waiting times for Leqembi antibody treatment could range from several months to even years in the next decade, depending on demand.

Bojian makes a comeback after the market abandonment of the previous drug

In June 2021, the FDA approved another Alzheimer's drug developed by Bojian called Aduhelm for market release. However, due to the lack of evidence demonstrating its ability to slow cognitive decline, industry experts believe that the clinical efficacy data for Aduhelm is insufficient to support its approval and therefore this drug failed to gain favor from doctors or insurance companies.

Subsequently, this drug faced a series of setbacks, including restricted use, poor sales, and the dissolution of the research team. The continuous blows caused Aduhelm to fall into a deep abyss, and Bojian consequently had to lay off employees to sustain its livelihood.