Explained: FDA approves new Alzheimer's medicine for early-stage patients, but what are the safety concerns?

Leqembi, anew Alzheimer's medicineis entering the market; it is the first to have conclusive proof that it can delay the mind-robbing condition by many months.Although a novel treatment that has been long overdue, several specialists are expressing concerns: The medication has certain safety issues, itis only meant for people in the early stages of their illness, and must be administered intravenously every two weeks. Even the extent to which that slight improvement will be perceptible in people's daily lives is unclear.

Still, “it’s a landmark,” said Dr. Richard Hodes, director of the National Institute on Aging, who spoke to AP.“It’s not enough, but it’s encouraging that there’s something we can do.”

Lecanemab, which will be sold under the brand name Leqembi, has been given the go-ahead by the Food and Drug Administration (FDA).

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Mechanism of the new medicine

Manufactured by the Japanese pharmaceutical company,Eisai and its American partner Biogen, the pill is designed to target and remove beta-amyloid, a sticky protein that accumulates into brain-clogging plaques and is a major indicator of Alzheimer's disease.

Dr. Sam Gandy, an Alzheimer's specialist at Mount Sinai Hospital in New York, who spoke to AP highlighted that it targets a slightly different version of that amyloid, potentially explaining why it was beneficial in rigorous research while several other amyloid-targeting medications have been unsuccessful in the past.

Despite no trials ever showing it actually benefitted patients, the FDA approved a similar medicine called Aduhelm in 2021. This decision drew considerable flak from a congressional probe.

How effective is this newAlzheimer's pill?

Leqembi appeared to postponethe aggravation of early-stage patients by roughly five months in Eisai's 18-month trial of about 1,800 participants.

On a scale of 1 to 18, which assesses cognitive and functional skills, A difference of over half a point on that scale at the conclusion of the research separated individuals who received the medicine from those who received dummy versions, but their conditions did worsen.

Opinions differ on the relevance of that advantage. Families could find it challenging to determine if a loved one's deterioration has slowed, according to Dr.Gandy who spoke to AP.

Even though it's difficult to detect, other specialists contend that slowing the illness early on, while people can still work normally, is crucial.

What are the risks involved?

Leqembi, like other amyloid-targeting medications, can result in brain edoema or minor brain bleeding. 13% of drug participants in Eisai's research reported edoema, while 17% had minor brain bleeds.

The most likely explanation is that amyloid plaques frequently develop around brain nerve cells, but they can also sometimes enter blood arteries. Dr.Gandy stated that removing amyloid from certain blood arteries might weaken and make them leaky.

While the symptoms of brain bleeding and swelling may be mild, such as headaches and blurred vision, they may also be severe, and some Leqembi users have passed away while taking the drug, including two who were using blood thinners.

The deaths, according to Eisai, cannot be linked to Alzheimer's medication. The biggest danger of significant bleeding, according to Dr.Gandy, would, however, be among Leqembi users who also take blood thinners, which are frequently used by elderly people to prevent or cure strokes.

Following the infusions, patients may also have brief side effects, such as fever, chills that mimic the flu, nausea, and changes in blood pressure.

Who is eligible for this medicine?

The medication is exclusively meant for those with very early-stage Alzheimer's disease who also have the characteristic amyloid accumulation.

When prescribing Leqembi to patients who are on blood thinners, clinicians are advised by the FDA to use caution. Additionally, throughout the course of treatment, patients will be advised to undergo many brain scans.

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It's uncertain how long patients should continue receiving the twice-monthly IV treatments as their condition steadily deteriorates. Longer-term follow-up with study participants is being conducted, and other studies are looking into even early usage – before those with amyloid buildup have symptoms.

When will it be available to patients?

It should be accessible by 23 January 2023, as per Eisai, but most patients will probably have to wait months to purchase it.

The reason for this is that health insurers are obliged to carefully evaluate the drug's efficacy before choosing whether to cover it, which patients should receive it, and what testing may be necessary to ensure they are suitable candidates.

The medicine is not anticipated to be covered by Medicare, which provides coverage for the majority of Alzheimer's patients, until later this year. This is because the Medicare programme for seniors only covers Alzheimer's medications that have gained complete FDA clearance, but Leqembi's permission was given expediently based on findings from earlier research. That bigger 18-month research is about to be reviewed by the FDA in expectation of final clearance later this year.

About the pricing

For a normal year of therapy, the IV medicinewill cost roughly US$26,500. The majority of consumers won't spend anything close to that much if their insurance covers it, but those whose plans force them to pay for a bigger share of their prescription prices may pay thousands of dollars annually.

(With inputs from agencies)

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