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Alzheimer’s drug Leqembi backed by FDA expert panel for full approval

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Breakthrough Alzheimer’s drug Leqembi has received the unanimous support of a US Food and Drug Administration advisory panel – all but ensuring full approval for the first of its class treatment.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 6-0 that data showed Leqembi – also known as lecanemab – demonstrated a clinical benefit to patients.

The PCNS came to its decision after reviewing evidence from a Phase 3 Clarity AD clinical trial that showed Leqembi slowed cognitive and functional decline in patients by 27% compared to a placebo at 18 months.

The FDA will decide on July 6 whether to endorse the drug made by Japanese pharmaceutical company Eisai and Massachusetts-based global biotechnology firm Biogen.

Leqembi received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023 and was launched in the US on January 18 this year.

The accelerated approval which allows for faster consent for drugs for serious conditions that fill an unmet medical need, was based on Phase 2b data that demonstrated that Leqembi reduced the accumulation of amyloid-beta plaque in the brain, a neuropathological hallmark of Alzheimer’s disease.

But this approval restricted Leqembi, which is administered twice a month intravenously, to patients who could either pay $26,500 a year or, in the case of the US Government’s Medicare national health insurance programme for seniors and the disabled, to those who were enrolled on a clinical trial. This even though there are no clinical trials underway.

However, FDA approval would mean that Leqembi would become more readily available through Medicare with the agencies running the programme, The Centers for Medicare and Medicaid Services (CMS), having promised to broadly cover the cost of the drug for patients who are willing to take part in a national data registry to track “evidence about how these drugs work in the real world.”

But that listing has yet to be created and the US-based Alzheimer’s Association has described making registry a condition of coverage an “unnecessary and potentially harmful barrier.”

Joanne Pike, the Alzheimer’s Association’s president and CEO, said: “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks.

“Now all eyes turn to CMS. Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval.

Alzheimer’s drug Leqembi. Image: Eisai Co.

“Americans living with Alzheimer’s disease deserve access to FDA-approved therapies without barriers, just like people with cancer, heart disease and HIV/AIDS.”

According to the Alzheimer’s Association, 6.5 million Americans are currently living with the disease, which robs patients of their memory and causes other cognitive problems.

The organisation says Alzheimer’s and other dementias will cost the US $345bn this year. That cost is predicted to rise to $11bn annually by 2050 as more people are diagnosed with the condition.

Leqembi, which is an anti-amyloid treatment, changes the course of Alzheimer’s and has been shown to deliver clear clinical benefit for people in the early stages of the disease.

By slowing progression in the early stages of Alzheimer’s, the treatment will give people more time to participate fully in daily life, help make important decisions, and live independently.

This could mean more time for a person to take care of family finances, and engage in hobbies and interests.

Phase 3 data from the Clarity AD global clinical trial published in the New England Journal of Medicine showed Leqembi met both the primary and all key secondary endpoints for the patient population with highly statistically significant results.

As with other anti-amyloid treatments in this class of drugs, Leqembi does have side effects, including brain swelling and bleeding.

Three deaths from brain haemorrhages occurred in the extended part of the trial. The FDA said the patients had a disorder called cerebral amyloid angiopathy, which is the build up of amyloid in small arteries and capillaries in the brain, a condition that can be difficult to detect by imaging tests.

Despite this, Dr Pike has welcomed the FDA Advisory Committee’s decision. She said: “The Alzheimer’s Association welcomes and celebrates this action by the FDA Advisory Committee to support traditional approval of Leqembi for people with early Alzheimer’s.

“With this action we are one step closer to more people living with Alzheimer’s having more time with more of their capabilities intact – to do the things they want to do and love to do best.”

Myra Garcia, a member of the Alzheimer’s Association Early Stage Advisory Group, spoke to the committee hearing and said: “While the thought of a cure for Alzheimer’s disease is certainly part of my optimism, I’d like you to know that for me, more time is enough for now. And that is the promise of treatments like lecanemab.”

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