FDA approves licence for anti-amyloid drug to treat Alzheimer's disease

This comes less than two years since the FDA approved the first licence for aducanemab, a new drug that caused controversy and was not approved for use in Europe by the European Medicines Agency (EMA).

Known commercially as Leqembi, the drug first made headlines in the UK in September last year and the data for it is far clearer cut, Alzheimer’s Research UK says.

The registered charity says: “The ruling means doctors can now prescribe lecanemab to people living in the US with a confirmed diagnosis of mild cognitive impairment (MCI) or early-stage Alzheimer’s disease, who have appropriate medical insurance, or who can afford to pay for it directly​.”

Advocacy organisation, Voices of Alzheimer’s, (VOA) is led by people with lived experience of the disease. The decision was welcomed by the organization and said the approval must focus attention on Medicare’s discriminatory decision last year to block coverage for innovative treatments for those living with Alzheimer’s.

Lecanemab, is developed by Eisai and Biogen, which has demonstrated positive results in slowing Alzheimer’s. The FDA is expected to give full approval to lecanemab later this year.

VOA says that according to published and peer reviewed research findings, lecanemab has shown a slowing of decline of activities of daily living by 37 percent, a critical indicator of the quality of life of people living with Alzheimer’s and their care partners.  Additionally, clinical trial data showed that lecanemab delayed progression of cognitive loss by 27 percent compared to placebo, which could equate to months or years of benefit to patients in terms of engaging with loved ones and living independently.

Eisai and Biogen’s clinical trials enrolled 1,795 people with early Alzheimer’s who had evidence of the amyloid brain plaques believed to contribute to cognitive decline.

Voices of Alzheimer’s said that it continues to be concerned that the price of lecanemab and future breakthrough treatments will negatively impact their accessibility. As to safety, Dr. Sharon Cohen, a member of the VoA scientific advisory committee, asserted that the drug’s safety profile is “reasonable with low risks.”

“Once again​,” Dr. Cohen added, “some are trying to hold Alzheimer’s treatments to a higher standard than with other therapeutic areas​.”

Jim Taylor, President of Voices of Alzheimer’s and long-time care partner, said: “The FDA’s decision represents a milestone moment in the search for an effective treatment for Alzheimer’s​.”

These results, Taylor added, will add pressure on Medicare to reverse its blanket decision last year to refuse to cover the new treatments for Alzheimer’s.

“Based on the FDA’s decision and the new effectiveness data,” he said, “we will demand that the federal government change its discriminatory policies on coverage and allow for access to those who could benefit from the treatment​.”

Dr Richard Oakley, Associate Director of Research at Alzheimer’s Society, said: “Today’s exciting results offer our best hope yet for not only delaying symptom progression for people with early-stage Alzheimer’s, but, significantly, slowing the loss of quality of life for them and their carers. ​

This isn’t the end of the journey for lecanemab – it's being explored in further trials to see how well it works over a longer period and the difference it could make to people before their symptoms have even developed.”​

He said the safety of drugs is crucial and lecanemab did have side effects, but they will be closely looked at when decisions are made about whether to approve lecanemab, to see if the benefits outweigh the risks. 

'There is still a long way to go before we could see lecanemab available on the NHS, and we await clarity for how and when the approval process will take place in the UK, and whether regulators believe it is cost-effective,” he added. ​

Late last year, the Alzheimer’s Association filed a formal request with the Centers for Medicare and Medicaid Services that it reconsider a blanket decision to require further evidence before approving any of the drugs like lecanemab for coverage by Medicare. VOA strongly supports the Association’s request.

Last year’s decision by Medicare to severely limit coverage for anti-amyloid drugs was unprecedented. Experts say they can think of no other class of drugs that has been treated in such a way by Medicare.