2023-07-07 06:38:00
An Alzheimer’s treatment jointly developed by a US and Japanese pharmaceutical company has been officially approved by the US Food and Drug Administration (FDA) for the first time in the world. It is evaluated as a ‘milestone for overcoming dementia’ as it can slow the progression of dementia in early patients.
On the 6th (local time), the FDA announced that the Alzheimer’s treatment Rechembi (ingredient: Renecamab-Imbruvi), which received expedited approval in January this year, has proven its clinical effect, and will switch to commercial approval, which means official approval. Rechembi is a treatment developed by Eisai in Japan and Biogen in the U.S. It removes the brain protein beta amyloid, which is pointed out as the cause of dementia.
According to clinical data, patients who took Recambi every 2 weeks for 18 months slowed the progression of Alzheimer’s disease by regarding 5 months (27%) compared to the control group. On the ’18-point cognitive scale’, which evaluates cognitive functions such as memory and problem solving, patients taking Recambe showed a 0.5 point lower score than the control group taking placebo.
Teresa Buracchio, acting director of the FDA’s Center for Drug Evaluation and Research, said, “We have demonstrated for the first time that a drug that targets the underlying disease process of Alzheimer’s showed clinical effects,” adding, “It has been proven to be a safe and effective treatment.” Prior to Rechembi, Aduhelem (ingredient: aducanumab) developed by Aci-Biogen received expedited approval, a conditional approval for urgent treatment, in 2021, but it did not reach normal approval.
Domestic dementia treatment experts welcomed it. Park Gun-woo, a professor of neurology at Korea University Anam Hospital (honorary president of the Korean Dementia Society) said, “The development of a drug that suppresses the root cause of dementia rather than just relieving symptoms is a huge step forward and gives hope to early patients.” According to the Central Dementia Center, as of the end of last year, it is estimated that there are regarding 960,000 dementia patients over the age of 60 in Korea.
However, the efficacy has not been proven in patients with advanced dementia, and even in patients with early dementia, the rate of cognitive function decline is slowed by 27%, so the effect itself is evaluated to be insignificant. In addition, the FDA issued a ‘black box warning’, the highest risk warning, saying that side effects such as cerebral hemorrhage and cerebral edema might be called. It is expected that it will be difficult to apply for national health insurance as the annual drug price is 26,500 dollars (34.61 million won). In the United States, the public health insurance Medicare said it covers regarding 80% of the cost.
New York = Correspondent Kim Hyun-soo [email protected]
Reporter Jo Geon-hee [email protected]
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