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丙肝最治疗药Sunvepra Capsules（Asunaprevir）

ID号：721 发布日期： 2014-09-03 截止日期：不限地区：全国浏览次数：450

Synthesis of Asunaprevir (Sunvepra), Bristol-Myers Squibb’s Breakthrough Hepatitis C Drug
Asunaprevir (Sunvepra, previously known as BMS-650032), an investigational NS3 protease inhibitor, is being developed by Bristol-Myers Squibb as a component of all-oral daclatasvir-based regimens for treating patients suffering from genotype 1 chronic hepatitis C infection (HCV). On July 7, 2014, the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir, 一般名:ダクラタスビル, 商品名:ダクルインザ, Bristol-Myers Squibb) and Sunvepra® (asunaprevir, 一般名:アスナプレビル, 商品名:スンベプラ, Bristol-Myers Squibb) to treat patients with genotype 1 hepatitis C virus infection. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

The dual direct-acting antiviral (DAA) regimen of daclatasvir, a NS5A replication complex inhibitor, and asunaprevir was granted breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) on February 24, 2014. This marks second breakthrough therapy designation for a regimen containing daclatasvir.

In 2013, the all-oral triple DAA treatment regimen of daclatasvir, asunaprevir and a non-nucleoside NS5B polymerase inhibitor BMS-791325 also received FDA breakthrough therapy designation.

In November 2013, an all-oral combination of daclatasvir and asunaprevir were submitted for approval in Japan for hepatitis C, seeking “the world’s first interferon- and ribavirin-free treatment regimen” for the disease. The regulatory filing of the dual regimen in the US is targeted in the first half of this year (2014). Bristol-Myers Squibb is also seeking EU approval of daclatasvir combined with other agents for treating chronic hepatitis C. The three drug regimen is currently in phase III clinical trials.

Bristol-Myers Squibb lags behind Gilead Sciences (all oral regimen of sofosbuvir and ledipasvir) filed with Food and Drug Administration in February 2014) and AbbVie (all-oral regimen filing expected in 2014) in the highly lucrative Hepatitis C market.

Synthesis of Bristol-Myers Squibb’s NS3 protease inhibitor Asunaprevir （Sunvepra）for the treatment of Hepatitis C 百时美施贵宝公司丙肝治疗药物Asunaprevir的化学合成

At the April 9-13,2014 the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London, Bristol-Myers will present data for Daclatasvir in Multiple Investigational All-oral Combinations across Hepatitis C Genotypes

The list of Bristol-Myers Squibb presentations for Hepatitis C: Direct-Acting Antiviral Data is shown below. Abstracts can be accessed on the ILC/EASL website at http://www.ilc-congress.eu.

April 12,2014 15:30 – 17:30
Oral Presentation (late-breaker): All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1b infection: Phase 3 study results

April 10,2014 09:00 – April 12,2014 18:00
Poster (late-breaker): Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1b: Results of the HALLMARK DUAL study

April 11,2014 16:00 – 18:00
Oral Presentation: Effect of baseline NS5A polymorphisms on virologic response to the all-oral combination of daclatasvir + sofosbuvir ± ribavirin in patients with chronic HCV infection

April 12,2014 09:00 – 18:00
Poster: Effect of ribavirin on the safety profile of daclatasvir + sofosbuvir for patients with chronic HCV infection

April 12,2014 09:00 – 18:00
Poster: All-oral therapy with daclatasvir in combination with asunaprevir and BMS-791325 for treatment-naive patients with chronic HCV genotype 4 infection

April 12,2014 09:00 – 18:00
Poster: Daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose combination: A phase 1 bioavailability study in healthy volunteers

Ｃ型肝炎治療薬「ダクルインザ」「スンベプラ」承認取得
2014年７月４日、ブリストル・マイヤーズ株式会社は、日本初のインターフェロン及びリバビリンを必要としない経口薬のみによるC型慢性肝炎の治療
・「ダクルインザ(R)錠60mg」（一般名：ダクラタスビル塩酸塩）
・「スンベプラ(R)カプセル100mg」（一般名：アスナプレビル）
を世界に先駆けて日本で製造販売承認を取得しました。

ブリストル・マイヤーズスクイブ社は、2014年7月4日、セログループ1（ジェノタイプ1）のC型慢性肝炎およびC型代償性肝硬変に対するインターフェロン及びリバビリンを必要としない経口薬のみによる治療法として、NS5A複製複合体阻害剤である「ダクルインザ®錠60mg」（一般名：ダクラタスビル塩酸塩）およびNS3/4Aプロテアーゼ阻害剤である「スンベプラ®カプセル100mg」（一般名：アスナプレビル）の製造販売承認を、世界に先駆けて日本で初めて取得したことを発表しました。

スンベプラ®の製品概要
商品名:スンベプラ
製品名:スンベプラ®カプセル100mg
一般名:アスナプレビル
欧文商品名: Sunvepra®
欧文一般名: Asunaprevir
製造販売承認取得日:2014年7月4日
製造会社:ブリストル・マイヤーズスクイブ社
効能: C型肝炎治療薬
ターゲット: HCV NS3 protease inhibitor
用法・用量: 通常、成人にはアスナプレビルとして1 回100 mg を1 日2回経口投与する。本剤はダクラタスビル塩酸塩と併用し、投与期間は24 週間とする。