施贵宝治疗丙肝口服鸡尾酒疗法获FDA突破性药物认证

施贵宝治疗丙肝口服鸡尾酒疗法获FDA突破性药物认证
作者：yangtao 来源：生物谷 2014-2-25
关键词： 施贵宝 丙肝 突破性药物 鸡尾酒疗法 丙肝治疗

                               
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2014年2月25日讯 /生物谷BIOON/ --制药巨头施贵宝公司日前宣布公司研发的以daclatasvir为基础的治疗丙肝口服鸡尾酒疗法获得了FDA突破性药物认证。去年施贵宝公司的另外一种丙肝鸡尾酒疗法同样得到了FDA突破性药物认证。此次获批的疗法是一种结合了daclatasvir（一种NS5A复制抑制物）和asunaprevir（NS3蛋白酶抑制物）疗法，主要是用于治疗1b基因型的患者。
丙肝治疗领域的竞争一直十分激烈，此前Gilead曾推出治疗周期为12周的药物Sovaldi，同时Gilead公司还打算结合Sovaldi和ledipasvir开发自己的丙肝鸡尾酒疗法。而艾伯维也已经加入到这一竞争中希望在这一价值数十亿美元的市场中分一杯羹。因此此次施贵宝获得第二项突破性药物并不意味着其能在这场竟争中稳操胜券。（生物谷Bioon.com）
详细英文报道：
Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's ($GILD) pioneering approach.
The FDA tapped a combination of daclatasvir (an NS5A replication inhibitor) and asunaprevir (their NS3 protease inhibitor) for genotype 1b patients. Last spring their triple drug cocktail, which also includes BMS-791325, an NS5B non-nucleoside polymerase inhibitor, was tapped as a breakthrough for genotype 1 patients.
Bristol-Myers ($BMY) has been hustling along with its various combos as Gilead pushes Sovaldi into the marketplace at a pricey $84,000 for a 12-week treatment course. Gilead already has its sights set on a filing for a combination of its own--Sovaldi and ledipasvir--which would further crack open the multibillion-dollar market waiting for interferon-free hep C drugs. And AbbVie ($ABBV) has been hurrying along with its own combination cocktail for the disease. All these efforts have posted some solidly promising efficacy results in key studies.
Payers have been paying particularly close attention to this late-stage cocktail race as physicians warehouse various patient groups-divided by genotype--for the right therapy. Interferon injections frequently have a cruel and intolerable impact on patients, leaving the field wide open to new combination therapies with a high likelihood of success in quelling the virus. The pioneers are being priced high, and payers would like to see some competition start to bring prices down quickly.
A second breakthrough designation for BMS at this stage may not sound like much at first glance, but any advantage on the regulatory front could pay back handsomely with an earlier entry into the market. Sovaldi earned $139 million in the first three weeks it was on the market at the end of December. That left analysts projecting sales of $5 billion to $6 billion in 2014, which would make it one of the most successful new drug launches in industry history.


(责任编辑：lishuheng)