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Eisai and Biogen Get US FDA Approval for Alzheimer's Drug, Apply for Full Approval

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Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the early stages of the disease. .

Eisai and Biogen said Saturday that the Japanese drugmaker has applied for full FDA approval of the drug.

The drug, which will be sold under the brand name Leqembi, belongs to a class of treatments aimed at slowing the progress of neurodegenerative disease by removing sticky clumps of toxic beta-amyloid protein from the brain.

Almost all previous experimental drugs using the same approach have failed.

“Today’s news is incredibly important,” said Dr. Howard Fillit, scientific director of the Alzheimer’s Drug Discovery Foundation. make Alzheimer’s disease not just treatable, but preventable.”

Eisai said the drug would be launched at an annual price of $26,500. Shares of Biogen, which had been suspended, rose 3% to $279.40.

The Japanese company said it also plans to apply for marketing authorization for Leqembi in Japan and the European Union by the end of its marketing year on March 31, with the hope of gaining approval from the Japanese authority by the end of this year.

Eisai estimated that the number of US patients eligible for the drug would reach about 100,000 in three years, gradually increasing thereafter over the medium to long term.

“Our assumption is that the number of global patients eligible for the drug will grow to around 2.5 million by 2030,” Eisai CEO Haruo Naito told reporters and analysts on Saturday in Tokyo.

“The new drug may not generate a significant profit immediately after launch, but it will start to contribute to our profit in the second half of the second or third year,” he said, without giving any concrete numbers.

doctor Erik Musiek, a University of Washington neurologist at Barnes-Jewish Hospital, said he was “pleasantly surprised” by the drug’s price.

“Considering the market and the fact that we don’t have other good disease-modifying treatments, I think it’s within what I would expect,” he said.

Initial patient access will be limited by several factors, including reimbursement restrictions from Medicare, the US government’s insurance program for Americans age 65 and older, who represent about 90% of individuals likely to be eligible for Leqembi .

“Without Centers for Medicare and Medicaid Services (CMS) and insurance coverage…an assertion.

Leqembi has been approved through the FDA’s accelerated review process, an accelerated pathway that accelerates access to a drug based on its impact on underlying disease-related biomarkers believed to predict clinical benefit.

“This treatment option is the latest therapy to target and affect the underlying process of Alzheimer’s disease rather than just treating the symptoms of the disease,” FDA Neuroscience Officer Billy Dunn said in a statement.

CMS said on Friday that current coverage restrictions for drugs approved under the fast track may be reconsidered based on its continued review of available information.

If the drug receives traditional FDA approval, CMS said it would provide broader coverage. Eisai officials said the company plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.

CMS’s decision was largely in response to an earlier Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, gained fast-track approval in 2021 with little evidence that the drug slowed cognitive decline and over objections from outside FDA experts.

Biogen initially priced Aduhelm at $56,000 per year before cutting the price in half. With limited acceptance and insurance coverage, sales were just $4.5 million in the first nine months of 2022.

Lecanemab is intended for patients with mild cognitive impairment or early-onset Alzheimer’s dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing disease.

To receive the treatment, patients will need to undergo tests to show they have amyloid deposits in the brain – either through brain imaging or a lumbar puncture. They will also need to undergo periodic MRI scans to monitor brain swelling, a potentially serious side effect associated with this type of medication.

The drug’s label says that doctors should be careful if lecanemab patients receive blood clot preventatives. That could be a safety risk, according to an autopsy analysis published this week of a lecanemab patient who had a stroke and subsequently died.

In the big trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s by 27% compared with a placebo. Nearly 13% of Leqembi-treated patients in the study had brain swelling.

The Doctor. Babak Tousi, a neurogeriatrician at the Cleveland Clinic, said the approval will make a “big difference” in the field because it is based on biomarkers and not just symptoms.

“This will change the way we diagnose Alzheimer’s disease more accurately,” he said.

Tousi acknowledged that the drug’s benefit is likely to be modest. “Even so, it is a benefit that we could not achieve” before this approval.

Reporting by Deena Beasley in Los Angeles and Bhanvi Satija in Bengaluru; Additional reporting by Jaiveer Shekhawat in Bengaluru and Yuka Obayashi in Tokyo; Editing by Bill Berkrot, David Gregorio, William Mallard and Tomasz Janowski

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