Eisai receives US FDA approval for Biogen Alzheimer’s drug, files for full approval

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

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

The drug, which will be sold under the brand name Legembi, belongs to a class of treatments that aim to slow the progression of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.

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

Senior researcher of the Alzheimer’s Drug Discovery Foundation, Dr. “Today’s news is incredibly important,” said Howard Fillitt. “Years of research into the most complex disease facing humans is paying off, giving us hope that we can prevent it. “Alzheimer’s is not only treatable, but also preventable.”

Eisai said the drug will be available at an annual cost of $26,500. Biogen shares, which were suspended, rose 3% to $279.40.

The Japanese company also said it plans to apply for marketing authorization for Legembi in Japan and the European Union by the end of the business year on March 31.

Eisai estimated that the number of U.S. patients eligible for the drug would reach about 100,000 within three years and gradually increase from there over the medium to long term.

Barnes-Jewish Hospital, Washington University neurologist Dr. Eric Musiek said he was “pleasantly surprised” by the price of the drug.

“Given that we don’t have the market and other good disease-changing treatments, I think it’s in the ballpark of what I would expect,” he said.

Initial patient access will be limited by a number of factors, including reimbursement limits by Medicare, the US government insurance program for Americans 65 and older, who represent approximately 90% of those who may be eligible for Legembi.

“For those who can benefit from the Centers for Medicare and Medicaid Services (CMS) and without insurance coverage… the newly approved treatment will be available only to those who can pay out of pocket,” the Alzheimer’s Association said. statement.

Legembi was approved under the FDA’s accelerated review process, an expedited pathway that speeds access to a drug based on its effect on key disease-related biomarkers believed to predict clinical benefit.

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

CMS said Friday that existing coverage limits for drugs approved under the fast track may be revised based on an ongoing review of available data.

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 Legembi.

The CMS decision was largely a response to earlier Alzheimer’s treatments from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021 despite objections from outside FDA experts, with little evidence that the drug causes cognitive decline.

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

Lecanemab is designed for patients with mild cognitive impairment or early Alzheimer’s dementia, which doctors say represents a small fraction of the roughly 6 million Americans currently living with the memory-robbing disease.

In order to receive treatment, patients must undergo a test to show that they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They also need periodic MRI scans to monitor for brain swelling, a potentially serious side effect associated with this type of medication.

The drug’s label states that doctors should use caution if lecanemab patients are given blood-thinning medications. This could be a safety risk, according to an autopsy analysis of a lecanemab patient who suffered a stroke this week and later died.

In a large trial of lecanemab given by infusion, the drug slowed the rate of cognitive decline in early Alzheimer’s patients by 27% compared to a placebo. About 13% of patients treated with Legembi in the trial had brain swelling.

Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, said the approval would make a “huge difference” in the field because it relies on biomarkers rather than just symptoms.

“This will change the way we diagnose Alzheimer’s disease with greater precision,” he said.

Tousi acknowledged that the drug’s benefit would likely be modest. “Again, that’s a benefit we’re not getting.”

Reporting by Deena Beasley in Los Angeles and Bhanvi Satija in Bengaluru, additional reporting by Jaiveer Shekhawat; Edited by Bill Berkrot, David Gregorio, and William Mallard

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