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 the Alzheimer’s drug lecanemab, made by Eisai Co Ltd ( 4523.T ) and Biogen Inc ( BIBO.O ), for patients in the early stages of the brain-wasting disease.

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

The drug, sold under the brand name Leqembi, is a class of treatment that aims to slow the progression of the neurodegenerative disease by removing the toxic protein beta amyloid from the brain.

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

“Today’s news is incredibly important,” said Dr. Howard Fillett, chief scientific officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into the most complex disease facing humanity is paying off and gives us hope that we can. It can not only treat but also prevent Alzheimer’s.

Eisai said the drug will start at an annual price of $26,500. Biogen shares were up 3 percent at $279.40 in after-hours trading.

The Japanese company said it plans to apply for marketing authorization for KMB in Japan and the European Union by the end of the operating year on March 31, hoping to get approval from Japanese authorities later this year.

Eisai estimates the number of U.S. patients eligible for the drug will reach around 100,000 within three years, increasing gradually over the medium to long term.

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“We estimate that the number of global patients eligible for the drug will grow to 2.5 million by around 2030,” Isaias CEO Haruo Naito told reporters and analysts in Tokyo on Saturday.

“The new drug may not generate much profit after it starts working, but it will start contributing to our profits by the middle of the second year or the end of the third year,” he said.

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

“Given the market place, we don’t have any other good disease-modifying treatments, so I think my expectations are in the ballpark,” he said.

Initial patient access will be limited by many factors, including Medicare reimbursement limits, which may qualify for coverage for 90% of Americans 65 and older under the U.S. government insurance program.

“Without Medicare and Medicaid Services (CMS) and insurance coverage … the newly approved treatment would be accessible to those who can afford to pay out of pocket,” the Alzheimer’s Association said. press release.

Leqembi was approved by the FDA’s accelerated review process, a fast-track pathway that speeds access to drugs based on disease-related biomarkers believed to predict clinical benefit.

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“This treatment option is the latest treatment to target the Alzheimer’s disease process, rather than just treating the symptoms of Alzheimer’s disease,” FDA neuroscience officer Billy Dunn said in a statement.

CMS said on Friday that coverage limits for drugs approved on an expedited basis may be reconsidered based on an ongoing review of available data.

If the drug gets traditional FDA approval, CMS said it would provide broader coverage. According to Esai officials, the company plans to submit data from a recent successful clinical trial in 1,800 patients based on a full formal evaluation of the drug.

The CMS decision is largely a response to earlier Alzheimer’s treatments from Issaie and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021, despite declining awareness of the drug and opposition from outside FDA experts.

Biogen originally cost AduHelm $56,000 a 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.

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

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

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The drug’s label says doctors should use caution if licanemab patients are given anticoagulants. That could be a safety concern, according to an autopsy analysis published this week of a licanumab patient who suffered a stroke and later died.

In a large trial of lichenumab, which is given by injection, the drug reduced the rate of cognitive decline in early Alzheimer’s patients by 27% compared to a placebo. In the trial, about 13% of patients treated with lekambi had brain swelling.

According to Dr. Babak Tusi, a neuro-geriatrician at the Cleveland Clinic, the approval represents a major change in the field because it is based on biomarkers, not just symptoms.

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

Tucci admits the drug’s benefits may be modest. Before this approval, “it’s a benefit we still haven’t been able to achieve.”

Reporting by Dina Beasley in Los Angeles and Bhanvi Satija in Bengaluru, additional reporting by Jaiveer 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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