Gilead公司提交新药申请到日本的药品和医疗器械局替诺福韦Al

StephenW

AASLD: Antiviral Activity of TAF Against Drug-Resistant HBV Isolates in Vitro - (01/07/16)

Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection - (01/05/16)

Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Tenofovir Alafenamide (TAF) for Patients with Chronic Hepatitis B Infection

-- High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 31, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), which is marketed in Japan for the treatment of HBV as Tenozet® by GlaxoSmithKline. TAF has also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.

“With more than one million people in Japan chronically infected with hepatitis B, there is a significant need for effective new treatment options that offer a favorable safety profile,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President of Research and Development and Chief Scientific Officer. “We are pleased with the results of the Phase 3 studies, which suggest that TAF has the potential to improve the care of chronic hepatitis B patients who require lifelong treatment to manage their disease.”

The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy (HBV DNA < 29 IU/mL at Week 48) compared to TDF among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection. Both studies enrolled patients from a number of clinical sites in Japan. Patients randomized to the TAF arms showed a statistically significant increase in serum alanine aminotransferase normalization relative to the TDF arms when using the American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment arms. Overall, patients receiving TAF experienced a significantly smaller percentage decrease from baseline in hip and spine bone mineral density at Week 48 compared to patients receiving Viread. Additionally, the overall change in serum creatinine from baseline to Week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.

TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established.

StephenW

AASLD：TAF的抗病毒活性对耐药HBV分离株体外 - （16年1月7日）

吉利德公布顶线结果从两个3期研究治疗慢性乙型肝炎病毒感染评估替诺福韦Alafenamide（TAF） - （16年1月5日）

Gilead公司提交新药申请到日本的药品和医疗器械局替诺福韦Alafenamide（TAF）治疗慢性乙型肝炎病毒感染

- 病毒抑制高房价和3期研究改善肾和骨安全参数相比Viread的 -

福斯特城 - （美国商业资讯） - 三月31，2016--吉利德科学公司（Nasdaq：GILD）今天宣布，该公司已经提交了新药申请（NDA），以日本药和医疗器械局（PMDA）替诺福韦alafenamide（TAF）25毫克，一个调查一次 - 每日治疗慢性乙型肝炎病毒（HBV）感染的成年人。

TAF是替诺福韦的新型靶向药物前体，已经证明高抗病毒效力类似，在一个剂量小于十分之一Gile​​ad公司Viread®（富马酸替诺福韦酯，TDF），这是在日本销售的用于治疗乙型肝炎的作为Tenozet的®由葛兰素史克公司。 TAF还展示了在临床试验中相比TDF肾和骨安全的替代实验室指标的改善。

“在日本超过一百万人感染慢性乙肝，对于能够提供一个良好的安全性有效的新的治疗选择一个显著的需要，”诺伯特Bischofberger，博士，Gilead公司的研发和首席科学的执行副总裁官。 “我们很高兴与第三阶段研究，这表明，TAF对提高护理谁需要终身治疗，管理自己的疾病的慢性乙肝患者的潜在的结果。”

在NDA的TAF是通过48周的数据来自两个3期研究，符合非劣效性的主要目标的疗效（HBV DNA <29 IU / mL的48周）之间的初治和处理 - 相比，TDF支持有经验的成年人HBeAg阴性和HBeAg阳性慢性HBV感染。这两项研究入选患者从众多日本临床场所。随机分配到TAF臂患者使用美国协会肝病标准研究时表现出相对于所述TDF臂血清谷丙转氨酶正常化有统计学显著增加。肾和骨骼实验室安全参数的变化的青睐TAF治疗武器。总体而言，接受TAF经历的患者在髋部和脊柱骨密度基线显著比例较小跌幅在48周相比，接受Viread的患者。此外，血清肌酐到48周的总体变化从基线青睐TAF。由于不良事件，最常见的不良反应停药率在接受TAF或Viread的患者相似。

TAF作为单一药剂治疗的HBV是一种研究产品及其安全性和疗效尚未确定。

齐欢畅2

好消息

MP4

来来来，想一起穷游日本的send me message

齐欢畅2

这个药上市后还是很贵的。真要买，只能买印度版的了。估计价格不会贵。