Alzheimer’s Drug Granted Accelerated Approval


Leqembi | Image by Eisai Co./NBC

A new drug that apparently slows the progression of Alzheimer’s has received accelerated approval by the FDA.

While Leqembi — the name under which lecanemab will be marketed — is not a “cure” for the disease, it does purport to help users maintain their cognitive abilities by slowing the brain disease in its early stages.

“This is a milestone for people eligible for this treatment, for their families, for the research community,” explained Maria Carrillo, chief science officer for the Alzheimer’s Association, which was not involved in the drug’s development.

According to a press release from the FDA, finding a treatment for Alzheimer’s disease has been difficult due to a lack of understanding of its causes. What is clearer is how it impacts the brain, slowly destroying neurons and their connections and irreversibly affecting an individual’s memory and thinking skills.

More than 6.5 million Americans suffer from this disease.

The new drug targets the progression of Alzheimer’s — rather than trying to reverse its symptoms — by removing a sticky plaque that builds up in Alzheimer patients’ brains called amyloid.

While other drugs have also targeted amyloid but failed to slow the loss of mental abilities in patients, the third phase of Leqembi’s trial produced promising results.

A total of 1,795 participants between the ages of 50 and 90 with early Alzheimer’s disease were involved in the study. While one group of 898 received lecanemab every two weeks, the other 897 received a placebo.

Over the course of 18 months, more than 76% of the group receiving lecanemab demonstrated reductions in amyloid plaques in the brain and 27% of them experienced a reduced depletion in mental abilities compared to those who were given the placebo.

Leqembi’s accelerated approval acts as a conditional allowance for the drug to be marketed because it has been shown to remove amyloid from the brain. The drug will likely be considered for full approval later this year, after the FDA has reviewed evidence suggesting that it also helps preserve mental function.

While Leqembi appears promising, it carries side effects similar to another drug, Aduhelm, which had also been granted a fast-tracked but controversial approval by the FDA in 2021. It may cause swelling or bleeding in the brain, which means that patients must undergo periodic brain scans while receiving treatment.

Cost is another issue. Leqembi was created through a partnership between drugmakers Eisai and Biogen, and they have priced the treatment at $26,500 a year. Thus, without insurance, these treatments would likely be out of reach for most people suffering from Alzheimer’s disease.

“Without coverage, we are talking about a breakthrough that is not available to the American public,” Carrillo asserted. “And that is not acceptable.”

In the case of Aduhelm, the Centers for Medicare and Medicaid Services ruled against providing coverage beyond the patients enrolled in certain trials, citing that the efficacy of the drug had not been clearly proven.

Those looking to take Leqembi will have to wait until it has full FDA approval to see whether it will be covered by Medicare.

Yet another pitfall is that, in order to even qualify for receiving treatment, patients will have to visit various specialists to confirm that they are in the early stages of the brain disease and that their brains have amyloid plaques. The cost and the long wait time would likely represent a significant challenge to many.

According to Jakub Hlávka, a health policy expert at the University of Southern California, those who may be currently eligible for Leqembi therapy may need to wait about five years to get cleared.

Nonetheless, Carrillo is confident the drug will be approved by the FDA and will change the lives of those who take it for the better.

“Maybe you could keep driving for an extra six months or a year,” she said. “Maybe you could keep doing your checkbook for an extra six months to a year.”

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27 days ago

Accelerated? I hope it won’t be like with covid vaccine, damaging healrh.