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【转帖】糖尿病新药长效Zafatek获得FDA批准上市

作者:admin 发布时间:2017.12.21 浏览:

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    糖尿病新药长效Zafatek获得FDA批准上市, 每周仅需服用一次!
    Takeda has become the first company to get approval for a once-weekly DPP-4 inhibitor for diabetes after its Zafatek product was cleared in Japan.
    The Ministry of Health, Labor and Welfare (MHLW) has given the nod to Zafatek (trelagliptin succinate) for the treatment of type 2 diabetes, giving it a lead over rival product omarigliptin from Merck & Co which was filed in Japan last November.
    Zafatek has the distinction of being the first once-weekly DPP-4 inhibitor to reach the market anywhere in the world, with the potential to improve patient adherence and - potentially - improve blood sugar control and reduce diabetic complications compared to the current short-acting products.
    At the moment Merck & Co's once-daily DPP-4 inhibitor Januvia (sitagliptin) is comfortably leading the market with sales of almost $4bn last year although sales have started to slide a little in the face of increasing competition in the category.
    There is not much agreement on the sales potential of the new once-weekly drugs, however, as the increased patient convenience has to be set alongside the fact that most patients are prescribed these drugs alongside metformin, which must be taken every day.
    Takeda licenses Zafatek from Furiex, which stands to receive royalties and sales-based milestone payments.
    Japanese product news in brief
    Zafatek's first world approval comes amid a flurry of other regulatory news from Japan, including the following product developments:
    - The MHLW has approved Gilead Sciences' Sovaldi (sofosbuvir) for the treatment of genotype 2 hepatitis C virus (HCV) infection with or without compensated cirrhosis in combination with ribavirin. Sovaldi is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection, and also the first product to be marketed by Gilead in Japan. Of the more than one million people chronically infected with HCV in Japan, 20%-30% have the genotype 2 strain of the virus.
    - Otsuka has been given a green light to market a new once-monthly formulation of schizophrenia treatment Abilify (aripiprazole) that has been on the market in the US since 2013 and Europe since 2014 as Abilify Maintena. There are around 710,000 people with schizophrenia in Japan, says the company, and medical costs and costs related to non-employment give rise to annual total cost burdens of approximately $23bn in addition to other societal costs.
    Meanwhile, the company has also submitted a marketing application forKeppra (levetiracetam) in the additional indication of adjunctive therapy for generalized tonic-clonic seizures.
    - GlaxoSmithKline (GSK) has been given the go-ahead by the MHLW to market its long-acting muscarinic antagonist (LAMA) Encruse (umeclidinium) for chronic obstructive pulmonary disease (COPD). The company also won Japanese approval for acne therapy Duac Combination Gel (clindamycin and benzoyl peroxide) and pneumococcal conjugate paediatric vaccine Synflorix.
    - Bayer has been granted approval for magnetic resonance imaging (MRI) agent Gadovist (gadobutrol) injection, which has been on the market since 1998 in Europe and is sold in more than 100 countries worldwide. The product is "the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan," according to Bayer.
    - Amgen/Astellas' PCSK9-targeting antibody Repatha (evolocumab) has been submitted to the MHLW for approval as a treatment for high cholesterol. Amgen has also filed the drug in the US, where it is expecting a decision by August 27, as well as in the EU.
    日本制药巨头武田近日宣布,糖尿病新药Zafatek(trelagliptin succinate,曲格列汀琥珀酸盐)获日本卫生劳动福利部批准,用于2型糖尿病的治疗。此次批准,标志着Zafatek成为全球上市的首个每周口服一次的降糖药,同时也代表着武田在糖尿病市场投下的一枚重磅炸弹。
    Zafatek由武田和Furiex研发,该药是一种超长效二肽基肽酶IV(DPP-4)抑制剂,每周口服一次,而市场上同类DPP-4抑制剂需要每天口服一次,Zafatek的用药优势无疑将为糖尿病患者提供了更为方便的治疗选择,有望大幅改善患者的便利性和依从性。
    目前,美国制药巨头默沙东也正在开发一款超长效DPP-4抑制剂omarigliptin,该公司于去年底向日本提交了全球首个监管申请。在临床试验中,omarigliptin疗效媲美自身年销40亿美元的每日一次DPP-4抑制剂Januvia(捷诺维,sitagliptin, 出国看病 ,西他列汀)。业界认为,omarigliptin将成为默沙东捍卫其口服降糖药市场霸主地位的重要筹码。
    据了解,DPP-4抑制剂是首类可通过提高机体自身能力控制血糖水平的新型2型糖尿病药物,可用作单药,也可与其它口服降糖药联用,其作用机制独特,具有不产生低血糖、不引起体重增加,以及副作用小等独特优势,同时引起胃肠道不良反应的发生率亦很低。

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  • freelane 编辑于 2015-03-30 23:46

  • • 听说病人都是这样判断医生的业务水平的~细思极恐
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