Eisai, Biogen Receive US FDA Approval for Alzheimer’s Drug and Apply for Full Approval

Eisai, Biogen Receive US FDA Approval for Alzheimer's Drug and Apply for Full Approval
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Jan 7 (Reuters) – The US Food and Drug Administration on Friday released Eisai Co Ltd. developed Alzheimer’s drug lecanemab approved (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting illness.

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

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

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

“Today’s news is incredibly important,” said Dr. Howard Fillit, chief science officer of Alzheimer’s Drug Discovery Foundation Being able to do it makes Alzheimer’s not only treatable, but preventable.”

Eisai said the drug would launch at an annual price of $26,500. Biogen shares, which had been halted, rose 3% to $279.40.

The Japanese company said it also plans to apply for market approval for Leqembi in Japan and the European Union by the end of its fiscal year on March 31, hoping to receive approval from Japanese authorities by the end of this year.

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 in the medium to long term.

“We expect that the number of eligible patients worldwide for the drug will increase to about 2.5 million by around 2030,” Haruo Naito, CEO of Eisai, told reporters and analysts in Tokyo on Saturday.

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

Dr. Erik Musiek, a Washington University 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 any other good disease-modifying treatments, I think it’s in the range of what I would expect,” he said.

Initial patient access is limited by a number of factors, including reimbursement restrictions imposed by Medicare, the US government insurance program for Americans age 65 and older, who make up approximately 90% of individuals probably eligible for Leqembi.

“Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage … access for those who could benefit from the newly approved treatment will only be available to those who can pay out of pocket,” the Alzheimer’s Association said in one Explanation.

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

“This treatment option is the latest therapy that targets and affects the underlying disease process of Alzheimer’s disease, rather than just treating the symptoms of the disease,” FDA neuroscientist Billy Dunn said in a statement.

CMS said Friday that current coverage limitations for drugs approved under the accelerated route may be reconsidered based on the ongoing review of available information.

If the drug gets traditional FDA approval, it would offer broader coverage, according to CMS. Eisai officials have said the company plans to provide data from a recently filed report successful clinical study in 1,800 patients as the basis for a full standard assessment of Leqembi.

The CMS decision was largely in response to previous Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, received accelerated approval in 2021 with little evidence the drug slowed cognitive decline and despite objections from the FDA’s outside experts.

Biogen initially priced Aduhelm at $56,000 per year before halving the price. With limited acceptance and insurance coverage, revenue for the first nine months of 2022 was just $4.5 million.

Lecanemab is intended for patients with mild cognitive impairment or early-stage Alzheimer’s dementia, a demographic that doctors believe makes up only a small portion of the estimated 6 million Americans currently living with the memory-wasting disease.

To receive treatment, patients must undergo tests to show they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They’ll also need to have regular 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 exercise caution when lecanemab patients are given anticoagulants. According to an autopsy analysis, this could pose a safety risk released this week of a lecanemab patient who had a stroke and later died.

In the large study of lecanemab, given as an infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s disease by 27% compared to a placebo. Almost 13% of the patients treated with Leqembi in the study had brain swelling.

Dr. Babak Tousi, a neurogeriatrician at the Cleveland Clinic, said the approval will make a “big difference” in this area because it’s based on biomarkers and not just symptoms.

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

Tousi acknowledged that the drug’s benefits are likely to be modest. “Nonetheless, it’s an advantage we couldn’t achieve prior to this approval.”

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

Our standards: The Thomson Reuters Trust Principles.

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