美國NBC電視台在7/2報導有關由Eli Lilly 公司推出的阿茲海默症藥物經第二階段的臨床試驗結果，獲得美國FDA的批准！茲將摘要譯為中文給予大家參考。

美國FDA 批准Alzheimer治療方法，該療法已被證明可以減緩記憶力下降

這種donanemab，是美國第二種可用治療Alzheimer的藥物，試驗顯示可以適度減緩記憶和思考能力的下降。

藥物 donanemab 將以 「Kisunla 」品牌銷售，是一種單株抗體輸注劑，每四週注射一次。
該藥廠表示，FDA 批准該藥物用於患有輕度認知障礙或早期阿茲海默症的成年人；「Kisunla 」的作用是針對大腦中的澱粉樣蛋白，這種蛋白被認為是阿茲海默症的一個標誌（hallmark）。
Mayo Clinic的神經科醫生Dr. Ronald Petersen說，這項批准意義重大，因為它為這種毀滅性疾病增加了另一種治療選擇。去年夏天，FDA 完全批准了一種名為 Leqembi 的類似藥物。Dr. Ronald Petersen說：
「這將為臨床醫生和患者提供選擇，」
據阿茲海默症協會稱，至2023 年，預計將有 670 萬 65 歲及以上的美國人患有阿茲海默症，而到 2060 年，這一數字將增至 1,380 萬人。
與同類藥物一樣，「Kisunla 」也具有潛在的危及生命的副作用，包括腦腫脹和腦出血。據 FDA 稱，儘管試驗中發現的大多數病例都是輕微的，但有三例死亡與該藥物有關。

然而最重要的是：
醫療保險可能涵蓋治療費用。
禮來公司表示，Kisunla 藥物12 個月的供應成本為 32,000 美元。

醫療保險預計將為該藥物提供承保。去年，醫療保險和醫療補助服務中心表示，它將支付獲得 FDA 完全批准的新阿茲海默症藥物的費用，儘管這將要求醫生收集有關藥物在現實世界中表現如何的數據。
FDA 最初定於三月就該治療做出決定，但後來將此決定稍微延後，以便從其顧問小組獲得更多關於其益處>副作用的咨詢（guidance）———（the benefits outweighed the side effects.）
上個月，FDA的外部專家委員會一致建議批准該藥物。
原文如下，供參考。

FDA approves Alzheimer’s treatment that has been shown to slow decline in memory
The drug, also called donanemab, is the second treatment available in the U.S. that has been shown in trials to modestly slow a decline in memory and thinking abilities.

Jul. 2, 2024, 1:42 PM EDT / Updated Jul. 2, 2024, 2:28 PM EDT

by Berkeley Lovelace Jr. | NBC NEWS

The Food and Drug Administration approved a new Alzheimer’s drug from Eli Lilly that has been shown in clinical trials to modestly slow a decline in memory and thinking abilities in people with the disease, the drugmaker said Tuesday.
The drug donanemab, which will be sold under the brand name Kisunla, is a monoclonal antibody infusion given every four weeks.
The FDA cleared the drug for use in adults with mild cognitive impairment or early Alzheimer’s disease, the drugmaker said. Kisunla works by targeting amyloid in the brain, considered a hallmark of Alzheimer’s disease.
The approval is significant because it adds another treatment option for the devastating disease, said Dr. Ronald Petersen, a neurologist at the Mayo Clinic. Last summer, the FDA granted full approval to a similar drug called Leqembi.
“It will give clinicians and patients a choice,” Petersen said.
An estimated 6.7 million Americans ages 65 and older were living with Alzheimer’s in 2023, according to the Alzheimer’s Association. The number is projected to increase to 13.8 million by 2060.
The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo. Decline was measured using the clinical dementia rating scale, which focuses on how well patients performed in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
The results were comparable to those seen with Leqembi.
Once a patient’s amyloid has reached very low levels, Eli Lilly expects they would be allowed to stop taking the treatment, the company has said. It is not yet known if or when the amyloid might come back, but if it does, a patient would likely need to restart the treatment.
Like other drugs in its class, Kisunla also comes with potentially life-threatening side effects, which include brain swelling and brain bleeding. Although most cases identified in the trial were mild, ​​three deaths were linked to the drug, according to the FDA.
Kisunla is now the second Alzheimer’s drug of its kind approved, behind Leqmebi. A third drug — Biogen’s Aduhelm — was taken off the market earlier this year.
Medicare likely to cover treatment
Pat Bishara, a 79-year-old mother of three from Carmel, Indiana, participated in both the phase 3 trial and the extension trial, which offered Kisunla to those initially given a placebo.
She was diagnosed with mild cognitive impairment in late 2017 and joined the trial in mid-2021.
Along with the monthly infusion, Bishara was also regularly evaluated by a psychologist. She had her final infusion on June 6.
Bishara said she had no noticeable side effects during the trial. Although she sometimes has trouble remembering peoples’ names, she said, most people might not even realize she has the disease. She attributes that to the treatment.
“I feel in my heart I wouldn’t be doing as well as I’m doing if I wouldn’t have been on something,” Bishara said.
Lilly said Kisunla will cost $32,000 for a 12-month supply.
Medicare is expected to provide coverage for the drug. Last year, the Centers for Medicare and Medicaid Services said it will pay for new Alzheimer’s drugs that are granted full FDA approval, although it will require physicians to collect data about how well the drugs perform in the real world.
The FDA was initially set to decide about the treatment in March but delayed the decision in order to get more guidance from its advisory panel on whether the benefits outweighed the side effects.
Last month, the agency’s committee of outside experts unanimously recommended the drug’s approval.