Eisai, Biogen gets US FDA approval for Alzheimer’s drug, applies for full approval

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 earliest stages of the mind-destroying 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 Leqembi, 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.

“Today’s news is incredibly important,” said Dr. Howard Fillitt, chief scientific officer of the Alzheimer’s Drug Discovery Foundation. made Alzheimer’s disease not just treatable, but preventable.”

Eisai said the drug will be released at an annual cost of $26,500. Biogen shares, which were 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 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, increasing gradually from there in the medium to long term.

Dr. Eric Musiek, 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 other good disease-modifying treatments, I think it’s within what I would expect,” he said.

Initial patient access will be limited by a number of factors, including limitations on reimbursement by Medicare, the US government insurance program for Americans age 65 and older, who represent about 90% of people likely to be eligible for Leqembi.

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

Leqembi was approved under the FDA’s accelerated review process, a fast track that speeds 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 disease process of Alzheimer’s rather than just treating the symptoms of the disease,” FDA neurology representative Billy Dunn said in a statement.

CMS said Friday that current coverage limits for fast-track approved drugs may be revised based on an ongoing review of available information.

If the drug gets traditional FDA approval, CMS said it would provide broader coverage. Eisai officials said the company plans to provide data from recently successful clinical trial in 1800 patients as the basis for a complete standard examination of Leqembi.

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

Biogen originally 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 Alzheimer’s dementia, a population that doctors believe represents a small segment of the roughly 6 million Americans currently living with the memory-robbing disease.

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

The drug’s label says doctors should use caution if blood clot preventers are given to lecanemab patients. This could be a safety risk, according to the autopsy analysis published this week of a lecanemab patient who had a stroke and later died.

In a large trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s disease by 27 percent compared with a placebo. Nearly 13% of patients treated with Leqembi in the study experienced brain edema.

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

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

Tousi acknowledged that the drug’s benefit would likely be modest. “Still, that’s a benefit we weren’t able to achieve” prior to this approval.

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

Our standards: Thomson Reuters Trust Principles.

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