US authorities expand approval for new drug that slows deterioration in Alzheimer's patients

On Thursday, US authorities expanded the licensing for the use of a new Alzheimer's drug "Leqembi" and made it more broadly available. Initially, its use was limited to a certain category of patients, but now it has been made more accessible through the federal health insurance system.

The US Food and Drug Administration (FDA) had previously approved in January the use of this new treatment for patients who have not yet reached the advanced stages of the disease. The treatment works by slowing cognitive decline.

The agency has authorized these two drugs under expedited procedures. However, the analysis of additional studies has enabled the broadening of the permission to use the drug, as explained by the agency.

The new treatment, which is administered intravenously every two weeks, was developed by Japanese pharmaceutical group Eisai, in collaboration with US company Biogen.

Up until now, this drug was not covered by the federal "Medicare" health coverage system for people over 65, unless it was being used in clinical trials. This significantly limited access to the drug.

Chiquita Brooks-LaSure, the head of the agency that manages "Medicare", said in a statement that the full authorization from the FDA will now allow the drug to be covered "on a broad scale." She added, "This is good news for millions of people across the United States who live with this debilitating disease and their families."

However, patients will still have to pay a portion of the cost out of pocket (20 percent, which amounts to thousands of dollars), according to the statement.

The new drug, which has "Lecanemab" as its active ingredient, belongs to a new generation of drugs that target beta-amyloid protein deposits. While the exact cause of Alzheimer's disease is still unknown, the brains of patients show amyloid plaques that form around nerve cells and destroy them over time. This leads to memory loss. In advanced stages of the disease, patients become unable to perform daily tasks or even carry on conversations.

Leqembi was the first drug proven to reduce cognitive decline in patients who received it in clinical trials by 27 percent.

However, the drug is accompanied by a warning of potential severe side effects, including a cerebral hemorrhage or brain swelling that could lead to death.

Joan Pike, president of the Alzheimer's Association, said in a statement that "this drug, although not a cure for the disease, can help give those affected more time... to maintain their independence and do the things they love."

She added that those afflicted with the disease "deserve the opportunity to consult with their doctor and their families and decide whether this drug is appropriate for them."

Leqembi is the second Alzheimer's treatment recently approved by the FDA, following "Aduhelm", which was approved in June 2021, and was also developed by Eisai and Biogen. It targets amyloid plaques as well. Aduhelm was the first drug approved in the US for the disease since 2003.

However, this treatment caused significant controversy, as the FDA opposed the opinion of an expert committee who believed the treatment did not sufficiently prove its effectiveness during clinical trials. The agency later restricted its use, confining it to those who suffer from mild cases of the disease.

Similarly, the American pharmaceutical company Eli Lilly is working on a drug that has shown a noticeable 35 percent slowdown in cognitive decline in Alzheimer's patients who have a high level of beta-amyloid and a decrease in tau protein.

 

AFP