Eisai, Biogen get US FDA nod for Alzheimer’s drug, apply for full approval

Jan 7 (Reuters) – The US Food and Drug Administration on Friday approved lecanumab, an Alzheimer’s drug developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients with the early stage of the brain-damaging disease. Gave.

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

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

Almost all previous experimental drugs using a similar approach had failed.

“Today’s news is incredibly important,” said Dr. Howard Fillitt, chief science officer for the Alzheimer’s Drug Discovery Foundation. Make Alzheimer’s not only curable, but also preventable.”

Eisai said the drug would launch at an annual cost of $26,500. Shares of Biogen, which remained halted, were up 3% at $279.40.

The Japanese company said it also plans to apply for marketing authorization for Lekambi in Japan and the European Union by the end of its business year on March 31.

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

Dr. Eric Musik, a neurologist at the University of Washington 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 ballpark of what I expected,” he said.

Initial patient access will be limited by several factors, including reimbursement restrictions by Medicare, the U.S. government’s insurance program for Americans age 65 and older, who represent about 90% of individuals likely to be eligible for Lekembi. Let’s keep

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

Leqembi was approved under the FDA’s accelerated review process, an expedited path that speeds access to a drug based on its effect on a biomarker related to the underlying disease believed to be of clinical benefit. makes predictions.

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

CMS said on Friday that existing coverage restrictions for drugs approved under the expedited route may be reconsidered based on an 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 Leqembi.

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

Adhelm initially cost $56,000 per year before Biogen cut the price in half. With limited approval and insurance coverage, sales in the first nine months of 2022 were only $4.5 million.

Lecanimab 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 disease. Is.

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

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

In a large trial of lecanimab, which is given by infusion, the drug slowed the rate of cognitive decline by 27% compared to a placebo in patients with early Alzheimer’s. About 13% of patients treated with Lekembi in the trial had swelling of the brain.

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

“This is going to change how we diagnose Alzheimer’s disease with greater accuracy,” he said.

Tousi acknowledged that the drug’s benefit is likely to be modest. “Nevertheless, this is a benefit that we would not have been able to achieve prior to this approval”.

Reporting by Dina Beasley in Los Angeles and Bhanvi Satija in Bengaluru, Additional reporting by Jaiveer Shekhawat; Editing by Bill Bercott, David Gregorio and William Mallard

Our Standards: The Thomson Reuters Trust Principles.

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