中国造生物药Trogarzo首次在美国上市，HIV治疗迎来新希望

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rufengzidie 发表于 2018-3-9 09:48:43 | 只看该作者回帖奖励

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本帖最后由 rufengzidie 于 2018-3-9 09:55 AM 编辑

重磅 | Made in China!中国造生物药首次在美国上市，HIV治疗迎来新希望2018-03-07 中国食品药品监管杂志

3月7日（美国时间3月6日），美国FDA宣布正式批准药明生物合作伙伴中裕新药（TaiMed）的Trogarzo（ibalizumab-uiyk）上市，作为一种全新的抗逆转录病毒疗法，治疗现有多种疗法均无法起效的**HIV感染者。Trogarzo（ibalizumab-uiyk）一种新型抗逆转录病毒药物，用于艾滋病毒**患者，这些患者过去曾尝试使用多种HIV药物，但HIV感染无法被其它目前可用的疗法成功控制。

值得一提的是，这是美国FDA在2018年批准的首款创新生物药，此项目也是药明生物首个商业化生产的项目，标志着药明生物跻身成为全球少数几个通过FDA GMP认证的生物药合作研发生产服务商（CDMO）。

Trogarzo是由中裕新药创制、药明生物协助生产的创新药物。它也是首例在中国生产、并得到美国FDA批准进入美国临床试验的无菌生物制剂。作为一种“病毒侵入抑制剂”，ibalizumab能够结合T细胞表面的HIV病毒主要受体CD4，以阻止这些细胞遭到病毒的入侵。作为10多年来首款具有全新作用机制的抗逆转录病毒疗法，ibalizumab曾获得美国FDA颁发的突破性疗法认定、优先审评资格、快速通道资格、以及孤儿药资格。

这款新药的安全性与疗效在一项临床试验中得到了验证。该试验招募了40名感染有多重耐药性HIV的患者，他们均重度经治，有些患者甚至已经接受过10种或更多的抗逆转录病毒疗法。然而即便接受了大量治疗，他们血液中的病毒水平（HIV-RNA）依旧很高。研究人员发现，在现有的疗法中额外加入Trogarzo的治疗后，只要短短一周，大部分患者血液中的HIV-RNA水平就有显著下降。24周后，43%的患者其HIV-RNA水平依旧得到了抑制。对于这些急缺治疗方案的患者，Trogarzo带来了显著益处。

FDA药物评估和研究中心抗病毒产品部副主任Jeff Murray博士表示：“虽然大多数艾滋病毒携带者可以使用两种或两种以上的抗逆转录病毒药物而被成功治疗，但过去服用过多种艾滋病毒药物的患者中有一小部分患有多重耐药性艾滋病，这限制了他们的治疗方案，令患者面临与HIV有关的并发症和病情恶化直至死亡等高风险。Trogarzo是新一类抗逆转录病毒药物中的第一个，可以为艾滋病毒治疗选择的患者提供显著益处。新疗法有希望改善这些患者的预后。”

欢迎阅读FDA新闻稿！

FDA News Release

FDA approves new HIV treatment for patients who have limited treatment opti**

March 6, 2018

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medicati** in the past (heavily treatment-experienced) and whose HIV infecti** cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medicati**.

“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment opti** and putting them at a high risk of HIV-related complicati** and progression to death,” said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Trogarzo is the first drug in a new class of antiretroviral medicati** that can provide significant benefit to patients who have run out of HIV treatment opti**. New treatment opti** may be able to improve their outcomes.”

The safety and efficacy of Trogarzo were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.

The clinical trial focused on the small patient population with limited treatment opti** and dem**trated the benefit of Trogarzo in achieving reduction of HIV RNA. The seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were c**idered in evaluating the Trogarzo development program.

A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion. The most common adverse reacti** to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system (immune rec**titution syndrome).

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designati**. Trogarzo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted approval of Trogarzo to TaiMed Biologics USA Corp.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency is also resp**ible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.