FDA Approves Ozempic (Semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults With Type 2 Diabetes and Chronic Kidney Disease
FDA Approves Ozempic (Semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults With Type 2 Diabetes and Chronic Kidney Disease
- Ozempic is now indicated to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease
- The approval is based on the results of the pivotal FLOW phase 3b kidney outcomes trial and addresses a critical need for adults with type 2 diabetes living with this common comorbidity of chronic kidney disease
- Ozempic現在被指示用於降低患有2型糖尿病和慢性腎病的成年人腎病惡化、腎衰竭和因心血管疾病導致死亡的風險。
- 該批准是基於關鍵的FLOW階段30億腎臟結局試驗的結果,滿足了患有慢性腎病的2型糖尿病成年人迫切需要。
PLAINSBORO, N.J., Jan. 28, 2025 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).1 This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class.
新澤西州普萊因斯堡,2025年1月28日 /PRNewswire/ -- 諾和諾德今天宣佈,美國食品和藥物管理局(FDA)已批准Ozempic用於降低2型糖尿病和慢性腎病(CKD)成年人腎病惡化、腎衰竭(終末期腎病)和因心血管疾病導致死亡的風險。1 這一批准與其現有的適應症一起,允許2型糖尿病成年人改善血糖控制,並減少已知心臟病成年人發生重大心血管事件的風險,使Ozempic(semaglutide)注射劑0.5毫克、1毫克或2毫克成爲其類別中適應症最廣泛的類似胰高血糖素肽-1受體激動劑(GLP-1 RA)。
Experience the full interactive Multichannel News Release here:
在這裏體驗完整的互動多通道新聞發佈:
"Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities. This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated," said Anna Windle, PhD, Senior Vice President Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk's commitment to cardiometabolic care."
"慢性腎病在患有2型糖尿病的患者中非常嚴重且普遍,在這些伴隨症狀的成年人中存在着重大需求。這一Ozempic的批准使我們能夠更廣泛地應對心血管-腎臟-代謝綜合症內的疾病,這種病症影響着數百萬成年人,如果不進行治療,可能會產生嚴重後果,"諾和諾德臨牀開發及醫療法規事務高級副總裁安娜·溫德爾(Anna Windle)博士說道。"憑藉這一新的適應症,Ozempic在其類別中獨樹一幟,成爲適應症最廣泛的GLP-1 RA。我們自豪地繼續推進創新,以對這一患者群體產生顯著影響,強調諾和諾德對心臟代謝護理的承諾。"
CKD affects approximately 37 million adults in the U.S. and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure.2,3 CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.2,4 For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death.4,5
慢性腎病大約影響着美國3700萬成年人,預計隨着人口老齡化和糖尿病的日益普遍(糖尿病是慢性腎病和腎衰竭的主要原因),這一數字將繼續上升。2,3 CKD是2型糖尿病的常見併發症,大約40%的2型糖尿病患者也患有CKD。2,4 對於2型糖尿病患者,CKD可以成爲一個重大負擔,並可能導致額外的疾病,包括增加心血管問題和死亡的風險。4,5
This FDA approval is based on results from the FLOW phase 3b kidney outcomes trial investigating the effects of once-weekly Ozempic injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.1 The FLOW trial achieved its primary endpoint with Ozempic 1 mg, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared to placebo, when added to standard of care.1
本次FDA批准基於FLOW階段30億腎臟結果試驗的結果,該試驗研究了每週一次注射Ozempic對2型糖尿病和慢性腎病成人主要腎臟和心血管結果的影響。FLOW試驗達到了其主要終點,使用Ozempic 1毫克顯示出相對於安慰劑在標準治療基礎上具有統計學意義的優越性,24%的相對風險降低,表明腎病惡化、腎衰竭(末期腎病)和因心血管疾病導致的死亡風險降低(3年內絕對風險降低4.9%)。
"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard E. Pratley, MD, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, and Co-Chair of the FLOW Trial. "A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients."
「在沒有慢性腎病的額外風險的情況下,管理2型糖尿病本身就已經非常具有挑戰性,我在自己的臨牀實踐中也看到,患有2型糖尿病和慢性腎病的患者需要額外的藥物支持,這可能通過降低重大腎臟和心血管結果的風險有深遠的臨牀影響,」Richard E. Pratley醫學博士,佛羅里達州奧蘭多市AdventHealth糖尿病研究所的醫學主任及FLOW試驗的共同主席表示。「我治療的患者中很大一部分經歷了嚴重的腎臟併發症和合並症,有些甚至需要透析。今天FDA的決定爲數百萬生活在這兩種病症中的成年人帶來了希望,並提供了額外的治療選擇,代表了對我的患者的重大進展。」
The FDA initially approved Ozempic in 2017 to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes. In 2020, Ozempic was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease. Today, the FDA has expanded the benefits of Ozempic to a new patient population that needs critical treatment options to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.
FDA最初於2017年批准Ozempic用於2型糖尿病成人在飲食和鍛鍊的基礎上改善血糖(葡萄糖)。在2020年,Ozempic獲得了額外的適應症,以降低已知心臟病的2型糖尿病成年人發生心臟病發作、中風或死亡等重大心血管事件的風險。今天,FDA將Ozempic的好處擴展到一個需要關鍵治療選擇的新患者群體,以降低2型糖尿病和慢性腎病成人腎臟病惡化、腎衰竭(末期腎病)和因心血管疾病導致死亡的風險。
Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic.
只有諾和諾德製造FDA批准的賽馬魯肽藥物,例如Ozempic。
About FLOW
FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing once-weekly Ozempic 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR < 15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, and CV death in adults with type 2 diabetes and CKD. 3,533 adults (1,767 in the Ozempic group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at approximately 400 investigator sites. The FLOW trial was initiated in 2019. At the recommendation from an Independent Data Monitoring Committee, the FLOW study was stopped early due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.6
關於FLOW
FLOW是一項國際性、隨機、雙盲、平行對照、安慰劑對照、事件驅動的優越性試驗,比較了每週一次的Ozempic 1 mg與安慰劑在標準護理基礎上對腎臟結局的影響,以減少主要複合終點(eGFR持續下降≥50%、eGFR持續
What is Ozempic
Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:
什麼是Ozempic
Ozempic(賽馬魯肽)注射劑0.5 mg、1 mg或2 mg是一種注射處方藥,用於:
- along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease
- to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease
- 結合飲食和運動改善2型糖尿病成年人血糖(葡萄糖)
- 減少已知心臟病的2型糖尿病成年人發生重大心血管事件(如心臟病發作、中風或死亡)的風險
- 減少2型糖尿病和慢性腎病成年人腎病惡化、腎衰竭(終末期腎病)及因心血管疾病導致死亡的風險
It is not known if Ozempic is safe and effective for use in children.
目前尚不清楚Ozempic在兒童中是否安全有效。
Important Safety Information
重要安全信息
Do not share your Ozempic pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
即使更換了針頭,也不要與他人分享你的Ozempic筆。你可能會給他人帶來嚴重感染,或從他們那裏感染嚴重疾病。
What is the most important information I should know about Ozempic?
Ozempic may cause serious side effects, including:
我應該知道關於Ozempic的最重要信息是什麼?
Ozempic可能會引起嚴重的副作用,包括:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic and medicines that work like Ozempic caused thyroid tumors, including thyroid cancer. It is not known if Ozempic will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use Ozempic if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- 可能的甲狀腺腫瘤,包括癌症。如果你在脖子上有腫塊或腫脹、聲音嘶啞、吞嚥困難或呼吸急促,請告知你的醫療保健提供者。這些可能是甲狀腺癌的症狀。在對齧齒動物的研究中,Ozempic和類似的藥物導致了甲狀腺腫瘤,包括甲狀腺癌。目前尚不清楚Ozempic是否會在人類中引起甲狀腺腫瘤或一種稱爲髓樣甲狀腺癌(MTC)的甲狀腺癌。
- 如果你或你的任何家庭成員曾經患有髓樣甲狀腺癌(MTC),或者如果你有一種叫做多內分泌腺瘤綜合症2型(MEN 2)的內分泌系統疾病,請不要使用Ozempic。
Do not use Ozempic if:
如果出現以下情況,請不要使用Ozempic:
- you or any of your family have ever had MTC or if you have MEN 2
- you are allergic to semaglutide or any of the ingredients in Ozempic. See symptoms of serious allergic reaction in "What are the possible side effects of Ozempic?"
- 您或您家族中是否有過甲狀腺髓樣癌(MTC)或是否有多發性內分泌腺瘤2型(MEN 2)?
- 您對semaglutide或Ozempic中的任何成分過敏。請參見"Ozempic可能的副作用有哪些?"中的嚴重過敏反應症狀。
Before using Ozempic, tell your health care provider if you have any other medical conditions, including if you:
在使用Ozempic之前,請告知您的醫療保健提供者您是否有任何其他醫療狀況,包括如果您:
- have or have had problems with your pancreas
- have a history of diabetic retinopathy
- have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic will harm your unborn baby or pass into your breast milk. You should stop using Ozempic at least 2 months before you plan to become pregnant
- 有或曾經有胰腺問題
- 有糖尿病視網膜病變的病史
- 有嚴重的胃部問題,例如胃排空緩慢(胃輕癱)或消化食物的問題
- 計劃接受手術或其他使用麻醉或深度鎮靜(深度催眠)的程序
- 您正在懷孕或哺乳,或計劃懷孕或哺乳。目前尚不清楚Ozempic是否會對您未出生的寶寶造成傷害或是否會進入您的乳汁。在計劃懷孕前,您至少應停止使用Ozempic 2個月。
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
告知您的醫療保健提供者您正在服用的所有藥物,包括處方藥和非處方藥、維生素、草藥補充劑以及其他治療糖尿病的藥物,包括胰島素或磺脲類藥物。
What are the possible side effects of Ozempic?
Ozempic may cause serious side effects, including:
Ozempic可能有哪些副作用?
Ozempic可能會引起嚴重的副作用,包括:
- inflammation of your pancreas (pancreatitis). Stop using Ozempic and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
- dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic. Tell your health care provider if you have stomach problems that are severe or will not go away
- serious allergic reactions. Stop using Ozempic and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
- gallbladder problems. Gallbladder problems have happened in some people who take Ozempic. Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your health care providers that you are taking Ozempic before you are scheduled to have surgery or other procedures
- 胰腺炎。如果您感到腹部(腹部)劇烈疼痛且疼痛持續不退,無論是否伴隨嘔吐,請立刻停止使用Ozempic並聯系您的醫療保健提供者。您可能會感覺到從腹部到背部的疼痛
- 視力變化。如果您在使用Ozempic治療期間有視力變化,請告知您的醫療保健提供者
- 低血糖(低血糖症)。如果您與可能導致低血糖的其他藥物(如磺脲類藥物或胰島素)一起使用Ozempic,您的低血糖風險可能更高。低血糖的跡象和症狀可能包括:頭暈或暈眩、視力模糊、焦慮、易怒或情緒變化、出汗、語言含糊、飢餓、困惑或嗜睡、顫抖、虛弱、頭痛、心跳加速和感覺緊張
- 脫水導致的腎臟問題。腹瀉、噁心和嘔吐可能會導致體液流失(脫水),這可能引起腎臟問題。重要的是您喝液體以幫助減少脫水的風險。如果您有持續的噁心、嘔吐或腹瀉,請立刻告知您的醫療保健提供者
- 嚴重的胃部問題。報道稱,一些使用Ozempic的人出現了有時嚴重的胃部問題。如果您有嚴重的或持續的胃部問題,請告知您的醫療保健提供者
- 嚴重過敏反應。如果您出現任何嚴重過敏反應的症狀,包括面部、嘴脣、舌頭或喉嚨腫脹;呼吸或吞嚥困難;嚴重皮疹或瘙癢;暈厥或感到頭暈;或心跳非常快,請立即停止使用Ozempic並尋求醫療幫助。
- 膽囊問題。某些服用Ozempic的人發生了膽囊問題。如果您出現症狀,請立即告知您的醫療保健提供者,症狀可能包括:上腹部(腹部)疼痛,發熱,皮膚或眼睛發黃(黃疸),或粘土色大便。
- 在手術或其他使用麻醉或深度鎮靜的程序中,食物或液體可能進入肺部。Ozempic可能增加在手術或其他程序中食物進入肺部的可能性。在您計劃進行手術或其他程序之前,請告知所有的醫療保健提供者您正在服用Ozempic。
The most common side effects of Ozempic may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.
Ozempic最常見的副作用可能包括噁心、嘔吐、腹瀉、腹部疼痛和便秘。
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
關於諾和諾德
諾和諾德是一家全球領先的醫療保健公司,已經爲糖尿病患者研發創新藥物,幫助他們過上更長、更健康的生活超過100年。這一傳統使我們積累了經驗和能力,也使我們能夠推動變革,幫助人們戰勝其他嚴重的慢性疾病,如肥胖、罕見的血液和內分泌疾病。我們始終堅信,持久成功的公式是保持專注,注重長期發展,並以財務、社會和環境負責的方式經營業務。諾和諾德在新澤西州設有美國總部,並在七個州以及華盛頓特區設有商業、生產和研究設施,員工約8,000人。欲了解更多信息,請訪問novonordisk-us.com,Facebook,Instagram和X。
Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications.
諾和諾德致力於負責任地使用我們的含有semaglutide的藥物,這些藥物代表了具有不同適應症、劑量、處方信息、調整日程和給藥形式的不同產品。這些產品不可互換,且不應超出其批准的適應症使用。
This information is intended for US media audiences only.
該信息僅供美國媒體受衆使用。
Contact for further information
Media:
Liz Skrbkova (US)
+1 609 917 0632 (Mobile)
[email protected]
聯繫以獲取更多信息
媒體:
莉茲·斯克爾博娃(美國)
+1 609 917 0632 (手機)
[email protected]
Jamie Bennett (US)
+1 640 250 1881 (Mobile)
[email protected]
傑米·貝內特 (美國)
+1 640 250 1881(手機)
[email protected]
References
參考文獻
- Ozempic (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2024.
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- National Kidney Foundation. Diabetes and chronic kidney disease. Last accessed: January 2025. Available at:
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