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

Eisai, Biogen Receives 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 lecanemeb made by Isai Co Ltd. (4523.T) and Biogen Inc (BIIB.O) For patients in the early stages of a debilitating disease.

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

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

Almost all previous experimental drugs using the same method failed.

“Today’s news is incredibly important,” said Dr. Howard Fillitt, chief science officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into what is one of the most complex human diseases has given us hope that we can. Make Alzheimer’s not just treatable, but preventable.”

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

The Japanese company said it plans to apply for marketing approval 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 estimates that the number of U.S. patients eligible for the drug will reach about 100,000 within three years, with gradual increases from there over the medium to long term.

“We think the number of patients worldwide eligible for the drug will increase to about 2.5 million by 2030,” Issai Chief Executive Officer 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 latter half of the second year or by the third year,” he said, without giving any specific figures.

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

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

Primary 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. Probability of qualifying For Lakembi.

“Except for the Centers for Medicare and Medicaid Services (CMS) and insurance coverage … for those who may benefit from newly-approved treatments, access will be available only to those who can pay out-of-pocket,” the Alzheimer’s Association said in a statement.

Lakembi was approved under the FDA’s accelerated review process, an accelerated pathway that speeds access to a drug based on its effect on underlying disease-related biomarkers believed to be predictive of a clinical benefit.

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

CMS said Friday that current coverage limitations for drugs approved under the expedited pathway 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 the latest Successful clinical trials As the basis for a full standard review of Lakembi in 1,800 patients.

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

Biogen initially priced Aduhelm at $56,000 before cutting the price in half. 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 that doctors believe represents a small portion of the estimated 6 million Americans currently living with the memory-robbing illness.

In order to receive the treatment, patients need to be tested to show that they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They should have periodic MRI scans to monitor for swelling of the brain, a potentially serious side effect associated with such drugs.

The drug’s label says doctors should use caution if lecanemab patients are given anticoagulants. According to the post-mortem analysis this could be a safety risk Published this week One lecanemab patient who had a stroke and later died.

In large trials of lecanemab, which is given by infusion, the drug reduced the rate of cognitive decline in early Alzheimer’s patients by 27% compared to a placebo. About 13% of patients treated with Lakembi 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 is based on biomarkers rather than just symptoms.

“It’s going to change how we diagnose Alzheimer’s disease with more precision,” he said.

Toussi acknowledged that the drug’s benefits would likely be modest. “However, this is an advantage that we could not achieve” prior to this approval.

Additional reporting by Dina Besley in Los Angeles and Bhanvi Satija in Bengaluru, Jayveer Shekhawat in Bengaluru and Yuka Obayashi in Tokyo; Editing by Bill Barkrot, David Gregorio, William Mallard, and Tomasz Janowski

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