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FDA Fully Approves Alzheimer’s Drug Meant to Slow Down The Disease

This Dec. 21, 2022 image provided by Eisai in January 2023, shows vials and packaging for their medication Leqembi. On Friday, Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease. The Food and Drug Administration granted the approval Friday for patients in the early stages of Alzheimer's. (Eisai via AP)

Photo Source: Denis Balibouse/Reuters

The FDA fully approved the drug, Leqembi on Thursday, which slows down the progression of Alzherimer’s disease within its patients. 

According to the Alzheimer’s Association, roughly 6.7 million seniors who are 65 and older have been diagnosed with Alzheimer’s in the U.S. 

Joanne Pike, president and CEO of the Alzheimer’s Association said in a statement that Leqembi could “give people in the early stages of Alzheimer’s more time to maintain their independence and do things they love.” 

“This gives people more months of recognizing their spouse, children and grandchildren,” said Pike. 

What is Leqembi and its side effects?

Leqembi is not a cure for Alzheimer’s. It is a treatment that slows down the cognitive decline for early-stage patients with the disease. The drug may extend how much longer a patient will have their memory.

In 2019, Eisai, a Japanese pharmaceutical company, conducted a large clinical trial of 1,795 early-stage Alzheimer’s patients. The data revealed that the drug may delay the progression by 27% over an 18-month period. 

“It’s a first step for hopefully more therapeutics in the future,” said Dr. Ronald Petersen, a neurologist, via email. 

This is the first approved drug that will slow down Alzeheimer’s progression, however it has several side effects. 

A patient using Leqembi may experience mild to moderate swelling or bleeding in the brain. This can either heal on its own or become life-threatening. The FDA is requiring a “black-box” warning on Leqembi’s label, saying “serious and life-threatening events,” may occur.

Medical professionals warn high-risk patients to be cautious when weighing the decision to undergo this treatment. This includes those who are on blood thinners, those who have experienced more than four bleeds in the brain, and those with APOE4, a gene mutation linked to Alzheimer’s. 

Another large clinical trial showed that about 13 percent of patients using Leqembi resulted in mild to moderate cases of brain swelling, while less than 2 percent of patients taking the placebo experienced swelling. However, the majority of these cases of swelling were resolved in a few months. 

The study also found that 17 percent of patients using Leqembi encountered brain bleeding, versus 9 percent of patients using the placebo.

How does Leqembi treatment work?

Leqembi, which is injected into the bloodstream every two weeks, will be for early-stage Alzheimer’s patients and those with symptoms of the disease. Approximately 5 million people in the U.S. with Alzheimer’s will not be eligible for the treatment because their memory and cognitive abilities are too far gone. 

According to Pam Belluck, a health and science journalist of the New York Times, the FDA requires that doctors test their patients for amyloid, a sign of Alzheimer’s. The patient must have “a buildup in the brain of the protein amyloid, which Leqembi attacks. Amyloid levels can be assessed with PET scans, spinal taps or newly available blood tests.”

How much do patients have to pay for Leqembi?

In addition to this medical breakthrough, Medicare agreed to cover 80 percent of the $26,500 annual cost of Leqembi. Patients would pay the remainder cost of $6,600, which still may be too expensive for many. Private insurance policies might pay a small portion or all of the co-payment that many Medicare patients have. 

Alzheimer’s experts said that those receiving Leqembi could cost up to $90,000 a year. Patients would be financially responsible for paying up to $18,000 per year after the 80 percent coverage.

Photo Source: MedicareFAQ
Photo Source: MedicareFAQ

If you or someone you know is experiencing mild symptoms of Alzheimer’s, medical experts urge potential patients to contact a specialist as there are so many factors to consider.

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