喜大普奔!吉利德丙肝鸡尾酒Harvoni获FDA批准!
2014-10-13 佚名 生物谷
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,
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.
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在此留言
#FDA批准#
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#ARVO#
73
丙肝新药很贵,需要到阿三那里去买。
57
这有什么喜的!不是中国上市!
163
#harvoni#
69
#鸡尾酒#
57
振奋人心,不知道乙肝什么时候可以取得这么大的突破
164