喜大普奔！吉利德丙肝鸡尾酒Harvoni获FDA批准！

喜大普奔！吉利德丙肝鸡尾酒Harvoni获FDA批准！吉利德（Gilead）是丙型肝炎领域的领军人物，明星药物Sovaldi销售已突破70亿美元。新一代丙肝鸡尾酒疗法Harvoni爆出好消息，该药已获FDA批准，是首个每日一次的复方单片鸡尾酒疗法，完全消除了利巴韦林（RBV）和注射药物干扰素。业界预测，该药年销售峰值将超过Sovaldi，达到100亿美元，同时将成为丙肝临床治疗的金标准。此外，Harvoni在欧盟监管方面也获得了建议批准的意见，预计年底将在欧盟上市。

10月10日，吉利德宣布，FDA已批准丙肝鸡尾酒疗法Harvoni（ledipasvir/sofosbuvir，90mg/400mg），用于基因型1丙肝（HCV）成人患者的治疗。Harvoni是首个每日一次的复方单片鸡尾酒疗法，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3个III期临床试验中，Harvoni 8-12周治疗方案临床治愈率（SVR12）达94%-99%，疗效媲美Sovaldi。而与Sovaldi相比，由于Harvoni完全消除了注射干扰素（interferon）和利巴韦林（RBV），该药将成为丙肝临床治疗的金标准。定价方面，吉利德已计划Harvoni 8周疗程定价为63000美元，Harvoni 12周疗程定价94500美元，比Sovaldi 12周疗程定价84000美元高1万美元。

业界预测，Harvoni的年销售峰值将突破100亿美元，这一数字将超过丙肝领域的突破性药物Sovaldi。另外，分析师也表示，由于丙肝是一个巨大的市场，而且此前临床医生已建议一些早期丙肝群体暂缓治疗等待Harvoni上市，因此已积累了庞大的待治丙肝群体，Harvoni年销售峰值100亿美元这一数字相对保守。

然而，Harvoni也不会是丙肝市场中唯一的全口服鸡尾酒疗法。在新一代丙肝鸡尾酒竞赛中，排在第二的艾伯维（AbbVie）研发的三合一丙肝鸡尾酒疗法，疗效媲美吉利德鸡尾酒Harvoni，已于今年4月向FDA提交申请，预计将在年底上市，仅比吉利德Harvoni晚2个月左右。而默沙东（Merck & Co）丙肝鸡尾酒疗法MK-5172/MK-8742在II期研究中所取得的骄人成绩，使行业分析师认为，该鸡尾酒一旦上市，将紧跟Harvoni，取得第二的好成绩。

本周，百时美施贵宝（BMS）爆出惊人消息，宣布放弃寻求FDA批准其二合一丙肝疗法的上市申请，而专注于开发疗程更短的丙肝治疗方案。这也意味着，在丙肝领域的激烈竞争中，吉利德可以腾出更多的时间。

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。强生（JNJ）上月耗资17.5亿美元收购Alios Biopharma公司，也有开发4周丙肝鸡尾酒疗法的计划。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。

另外，今年9月底，Harvoni在欧盟方面也获得了好消息，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已建议批准Harvoni。预计将在年底上市欧盟。（生物谷Bioon.com）

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英文原文：Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making

Gilead Sciences ($GILD) picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the need for painful injections that have plagued patients for years.

The drug combines NS5B-blocking sofosbuvir, already a blockbuster as Sovaldi, with ledipasvir, an NS5A inhibitor. In three Phase III studies on patients with the tough-to-treat genotype 1 variant of the virus, Gilead's combo notched cure rates as high as 99.1%, all without the use of interferon or ribavirin.

Harvoni is expected to peak at more than $10 billion a year, outstripping Sovaldi, the fastest-growing drug of all time. And that estimate may well be conservative, as analysts expect a huge uptick in prescriptions from doctors who have been effectively warehousing hep C patients until an injection-free treatment won approval. Prime Therapeutics, an insurer-owned pharmacy benefit manager, expects the resulting surge to increase the hep C cost burden on health plans by as much as 40% over 2014, which was already a record year. 

That's because curing the virus isn't cheap. As TheStreet's Adam Feuerstein reported, Gilead plans to sell its new combo pill at $94,500 for a 12-week regimen-roughly $10,000 more than the Sovaldi price that nearly set off a payer revolt--and $63,000 for 8 weeks of therapy, a shorter dosage approved for certain treatment-naive patients.

"Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well-tolerated," CEO John Martin said in a statement. "We are now working to ensure rapid and broad access to Harvoni."

But Harvoni won't be the only all-oral hep C treatment on the market for long. AbbVie ($ABBV), developing a three-drug cocktail with similar efficacy, is just a few months behind, filing with the FDA in April and expecting to commercialize its combo by year's end. Meanwhile, Merck's ($MRK) 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.

That said, Gilead will have a bit more elbow room in hep C with the surprise exit by Bristol-Myers Squibb ($BMY), which announced this week that it would abandon an effort to win FDA approval for a two-drug combo of its own, focusing instead on a long-term effort to develop shorter treatment options for the virus.

And Gilead's other rivals are thinking the same way, pursuing programs that could cure hep C in as few as four weeks. Merck splurged $3.9 billion on Idenix Pharmaceuticals in June to get its hands on some assets that, combined with its in-house treatments, could lead to speedy cures. And Johnson & Johnson ($JNJ), owner of the FDA-approved NS3/4A protease inhibitor Olysio, paid $1.75 billion for private biotech Alios BioPharma last month with a similar goal.

Harvoni picked up an endorsement from the European Medicines Agency last month, clearing the way for a likely continental approval near the end of the year.