The U.S. Food and Drug Administration (FDA) granted approval for Leqembi, an Alzheimer's disease drug developed by Japanese pharmaceutical company Eizai and Massachusetts-based Biogen on Thursday, July 6.
Leqembi, an antibody therapy for Alzheimer's, stands out as the first of its kind to receive full FDA approval. It also emerges as the first potential candidate for extensive coverage under Medicare, which pledged to provide insurance for the drug on the same day as its FDA approval, subject to certain conditions.
Medicare coverage proves crucial for aiding American senior citizens with early-stage Alzheimer's in affording treatment. Priced at $26,500 annually, Leqembi would be beyond the reach of most patients without insurance coverage. However, Leqembi cannot cure Alzheimer's. Clinical trials by Eizai showed that the therapy slowed cognitive decline caused by early-stage Alzheimer's by 27% within 18 months. The antibody drug is administered intravenously twice a month, targeting an amyloid protein associated with Alzheimer's.
Tanya Simuni, a Northwestern University Feinberg School of Medicine neurology professor and a member of the FDA advisory panel, conveyed that the benefits of Leqembi outweigh the risks. It offers an acceptable and beneficial treatment approach for this type of disease.
Robert Alexander, chairman of the Banner Alzheimer's Research Committee, stated that Leqembi clearly demonstrated its efficacy. He believes the research clearly proved its clinical benefits, with solid and robust results.
Joanna Pike, president of the Alzheimer's Association, said that while Leqembi can't cure the disease, it could help patients in the early stages maintain more independence, enabling them to manage their daily lives independently and spend more time with their families. She added that this would afford patients more time to recognize their spouses and offspring, safely, accurately, and promptly drive, manage family finances, and fully engage in hobbies and interests.
But, the treatment carries serious risks of brain swelling and bleeding. Three patients died during Eizai's clinical trials, and FDA scientists have yet to determine whether Leqembi was related to these deaths.
David Knopman, a neurologist specializing in Alzheimer's at Mayo Clinic in Minnesota, acknowledged that Leqembi clearly demonstrated benefits for patients in Eizai's trials, despite cautioning about the therapy's limited effects. He suggested that patients diagnosed and informed properly should weigh the treatment's pros and cons before deciding on using Leqembi.
Medicare plans to impose conditions on how it covers Leqembi. Patients diagnosed with early-stage Alzheimer's who are on Medicare must find a healthcare provider participating in the registration system. However, this system is contentious. The Alzheimer's Association and some congress members worry that this requirement could pose barriers to treatment.
Concerns exist that the number of healthcare providers participating in this type of registration could be limited, forcing people from rural and other underserved communities to travel great distances to find such providers.
The Centers for Medicare and Medicaid Services pledged to create a national portal that will allow healthcare providers to easily submit the data required for patients receiving Leqembi. The agency stated that the free-to-use portal would become available once the FDA approves the treatment method.
There are also concerns that if Leqembi is widely accepted as a treatment and demand for the antibody is high, there might not be enough specialists and locations to administer transfusions. Some studies estimate that wait times for Leqembi antibody treatment could range from a few months to even several years over the next decade, depending on demand.
In June 2021, the FDA approved another Alzheimer's drug developed by Biogen, Aduhelm, but it failed to find favor with doctors or insurance companies due to a lack of evidence suggesting it could slow cognitive decline. Subsequently, this drug faced a series of setbacks, including restricted use, poor sales, and the dissolution of the development team. These continuous blows plunged Aduhelm into the abyss, forcing Biogen into layoffs to sustain its operations. However, with the approval of Leqembi, Biogen has a chance to regain its footing.
