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The US Food and Drug Administration has approved the first Alzheimer’s drug to slow the progression of the neurodegenerative disease, paving the way for millions of American patients to access the treatment.
The regulator said on Thursday it would grant full approval to lecanemab, now known by the brand name Leqembi, which was developed by Japanese drugmaker Eisai and US biotech Biogen.
Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said a confirmatory study had shown that Leqembi was a “safe and effective treatment” for patients with Alzheimer’s.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” she said.
Chris Viehbacher, chief executive of Biogen, said the approval was a “breakthrough” in the treatment of Alzheimer’s. “We are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable,” he added.
More than 6.5mn Americans suffer from Alzheimer’s, which along with other dementias will cost the US about $345bn in 2023, according to the Alzheimer’s Association.
The drug is the first to tackle the progression of the disease, rather than just treat its symptoms. But some researchers are concerned that the effect on the rate of cognitive decline is not “clinically meaningful”.
Last month, the FDA’s panel of experts unanimously voted that Leqembi shows “clinical benefit”.
It comes after decades during which many big pharmaceutical companies lost hope and cut investment in Alzheimer’s research. Lecanemab was discovered by Swedish start-up BioArctic, which then partnered with the larger companies.
The FDA gave the drug accelerated approval in January, based on late-stage trial results that showed it slowed the rate of cognitive decline in early Alzheimer’s patients by 27 per cent.
Some patients in the trial experienced brain swelling and bleeding. Three of the 1,795 participants died from brain bleeds, including two people who were also taking blood-thinning medicines. Eisai said the drug could not be directly linked to the deaths.
Now that the drug has full approval, Medicare, the US government-backed insurance for seniors, will pay for it for early-stage Alzheimer’s patients, as long as their doctors participate in a database to collect evidence about how the drug works in practice. The drug will have a US list price of $26,500 a year, although health insurers will negotiate that down.
The Centers for Medicare & Medicaid Services decision to provide coverage for the treatment is crucial to enable a wide rollout of the treatment.
Its decision against widely covering Aduhelm, an Alzheimer’s drug from Biogen and Eisai — which secured a form of conditional approval two years ago — contributed to Biogen scrapping the commercial rollout. Aduhelm’s trial did not show as significant a benefit for patients as Leqembi and the data was controversial after one of the studies failed.
Patients in the EU will have to wait until early next year when the regulator is due to give its verdict on the drug. In the UK, Eisai submitted the drug for approval in May.
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