吉利德（Gilead）是丙型肝炎领域的领军人物，到目前为止，其明星药物Sovaldi（sofosbuvir）的销售额已突破70亿美元，而该公司正在开发的新一代丙肝鸡尾酒疗法LDV/SOF，近日在欧盟方面也传来了好消息，欧盟CHMP已建议批准LDV/SOF。美国方面，FDA预计也将在今年晚些时候批准LDV/SOF，商品名为Harvoni，该药预计将很快在欧美2大市场上市。Harvoni又将成为丙肝治疗领域的一枚明星药物。目前，业界也开始关注丙肝治疗的下一个前沿阵地，各巨头正竞相开发疗程为4周的丙肝鸡尾酒，有望在一个月内治愈丙肝。
近日，吉利德宣布，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已一致建议批准丙肝鸡尾酒疗法LDV/SOF，EMA通常都会采纳CHMP的意见，预计将在3个月内做出最终审查决定。丙肝鸡尾酒疗法LDV/SOF为每日一次的固定剂量复方片，由丙肝明星药物Sovaldi（sofosbuvir，SOF）和一种实验性NS5A阻断剂ledipasvir（LDV）组成，在临床试验中，经LDV/SOF（无利巴韦林）治疗12周，实现了100%的治愈率（SVR12）。
在新一代丙肝鸡尾酒竞赛中，吉利德依旧领先于其他竞争对手。排在第二的是艾伯维（AbbVie），该公司开发的三合一丙肝鸡尾酒疗法，疗效与吉利德LDV/SOF鸡尾酒疗效相似，于今年4月向FDA提交了上市申请，预计将在年底上市。而默沙东（Merck & Co）的丙肝鸡尾酒疗法MK-5172/MK-8742在II期研究中也取得了骄人的成绩。
业界预计，吉利德丙肝鸡尾酒疗法LDV/SOF又将成为丙肝领域的一枚明星药物，到2020年，该药的年销售额将突破30亿美元。
随着预期的监管批准，吉利德面临的下一个问题依然是定价问题。Sovaldi的售价为84000美元/疗程（12周），每片药物高达1000美元，这一价格已经令患者维权组织和政府部门极为不满，目前业界正密切关注吉利德如何对新一代丙肝鸡尾酒疗法LDV/SOF定价。
此外，在研发方面，制药巨头们已开始关注丙肝治疗的下一个前沿阵地。百时美施贵宝（BMS）已经启动一项研究，调查daclatasvir/asunaprevir/Sovaldi鸡尾酒疗法是否能在短短4周内治愈患者。而默沙东在今年6月耗资39亿美元收购Idenix制药获得相关丙肝资产，也正在积极开发4周丙肝鸡尾酒疗法。而同时，吉利德，为了捍卫其丙肝领域的领先优势，也已启动一项临床项目，评估4周丙肝鸡尾酒疗法。
英文原文：Gilead nears EU approval for the next big thing in hep C
Gilead Sciences ($GILD), already a trailblazer in hepatitis C treatment, is creeping up on its next milestone: approval for a combination therapy that promises to cure the majority of patients without the need for painful injections.
The European Medicines Agency has recommended continental approval for Gilead's new drug, which combines NS5B-blocking sofosbuvir, already a blockbuster as Sovaldi, with ledipasvir, an NS5A inhibitor. That recommendation now goes to the European Commission, which typically follows the EMA's guidance and hands down final decisions within about three months.
Meanwhile, Gilead has already filed an FDA application for the treatment, to be marketed as Harvoni, and expects to win approval and launch the drug later this year.
That should put it just ahead of its closest rivals in the race to cash in on next-generation hep C treatments. AbbVie ($ABBV), developing a three-treatment cocktail with similar efficacy, is just a few months behind, filing with the FDA in April and expecting to commercialize its combo by year's end. Bringing up the rear is Merck ($MRK), whose mix of MK-5172 and MK-8742 has charted impressive results in Phase II, leading analysts to pencil the company in for a second-place finish behind Gilead once it makes its way to market.
Gilead's combination is expected to bring in nearly $3 billion a year by 2020, sending annual sales of Sovaldi--already the fastest-growing drug of all time--north of $7 billion.
With regulatory approvals all but assured, Gilead's next hurdle will come in pricing. Sovaldi's cost, $84,000 for a 12-week regimen--nearly incited a payer revolt, and how the company chooses to price its next-gen combo will be closely watched.
Meanwhile, on the R&D side, the titans of hep C treatments are already focusing on the next frontier of treating the virus. Bristol-Myers Squibb ($BMY) has kicked off a study to determine whether a combination of its own daclatasvir and asunaprevir with Sovaldi can cure patients in as little as four weeks. Merck splurged $3.9 billion on Idenix Pharmaceuticals in June to get its hands on some assets that, combined with its in-house treatments, could do the same. And Gilead, looking to protect its lead, is researching a four-week program of its own.
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