创新药，中国造！热烈祝贺中裕新药创新HIV疗法获得FDA批准丨医麦优企秀
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2018年3月7日/医麦客 eMedClub/--2018年3月6日，美国食品药品监督管理局（FDA）批准Trogarzo（ibalizumab-uiyk），一种新型抗逆转录病毒药物，用于艾滋病毒成人患者，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。
Trogarzo由医疗专业人员每14天静脉注射一次，与其它抗逆转录病毒药物联合使用。
FDA药物评估和研究中心抗病毒产品部副主任Jeff Murray博士评论道：“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。”
"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。"
美国知名的专业媒体Endpoints第一时间报道，盛赞：中国制造：中裕新药赢得FDA批准，为耐药患者提供“突破性”HIV治疗
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FDA News Release
FDA approves new HIV treatment for patients who have limited treatment options
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 medications in the past (heavily treatment-experienced) and whose HIV infections 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 medications.
“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 options and putting them at a high risk of HIV-related complications 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 medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options 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 options and demonstrated 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 considered 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 reactions to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. 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 responsible 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.
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