Eisai, Biogen get U.S. FDA approval for Alzheimer’s drug, apply for full approval

Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved lacanemab, an Alzheimer’s drug developed by Eisai Co Ltd ( 4523.T ) and Biogen Inc ( BIIB.O ) for patients with early-stage brain tuberculosis.

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

The drug, to be sold under the brand name Lakembi, belongs to a class of treatments aimed at slowing 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 failed.

Alzheimer’s Drug Discovery Foundation Chief Science Officer Dr. “Today’s news is incredibly important,” said Howard Fillitt. Our years of research into one of the most complex diseases humans face is paying off and giving us hope that we can beat it. Make Alzheimer’s not only treatable, but preventable.”

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

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

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

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“We anticipate that the number of global patients eligible for the drug will reach about 2.5 million by 2030,” Issai CEO Haruo Naito told reporters and analysts in Tokyo on Saturday.

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

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

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

Early patient access will be limited by a number of factors, including reimbursement restrictions by 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 the Centers for Medicare and Medicaid Services (CMS) and insurance coverage… those who can benefit from newly-approved treatments will have access only to those who can pay out of pocket,” the Alzheimer’s Association said. a sentence.

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

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“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,” FDA neuroscience officer Billy Dunn said in a statement.

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

If the drug receives conventional FDA approval, CMS said it would provide broader coverage. Eisai officials have 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 Lekambi.

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

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

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

To receive treatment, patients will need to undergo testing to show that they have amyloid deposits in their brains—either through brain imaging or a spinal tap. They will also need periodic MRI scans to monitor brain swelling, a potentially serious side effect associated with this type of medication.

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The drug’s label says that doctors should use caution if blood thinners are given to patients on lacanemab. This could be a safety risk, according to an autopsy analysis published this week of a lacanemab patient who suffered a stroke and later died.

In a large trial of lacanemab, 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. About 13% of patients treated with Lacambi in the trial had brain swelling.

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

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

Toussi acknowledged that the drug’s benefit would be modest. “Still, that’s an advantage we couldn’t achieve” before the approval.

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

Our Standards: The Thomson Reuters Trust Principles.

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