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百时美丙肝新药Daklinza获欧盟批准

2019年03月22日 栏目:育儿

原标题:吉利德丙肝地位撼动——百时美丙肝新药Daklinza获欧盟批准——鸡尾酒治愈率达100%2014年8月27日讯 /生物谷BIOO

原标题:吉利德丙肝地位撼动——百时美丙肝新药Daklinza获欧盟批准——鸡尾酒治愈率达100%

2014年8月27日讯 /生物谷BIOON/ --丙肝治疗领域,吉利德可谓独领风骚,其明星药物Sovaldi(sofosbuvir)在今年上半年的销售额突破58亿美元,为其带来了滚滚财源。然而,这一格局即将打破。

近日,百时美施贵宝(BMS)丙肝新药Daklinza(daclatasvir)获欧盟批准,联合其他药物,用于所有1、2、3、4基因型慢性丙型肝炎(HCV)成人感染者的治疗。Daklinza是一种强效的泛基因型NS5A复制复合体抑制剂,在临床试验中,当与吉利德明星药Sovaldi组成一种全口服、无干扰素鸡尾酒疗法(Daklinza+Sovaldi)时,取得了100%的治愈率,包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患者群体。

目前,吉利德也在开发一种基于Sovaldi的丙肝鸡尾酒疗法ledipasvir/Sovaldi(LDV/SOF),百时美Daklinza/Sovaldi鸡尾酒疗法的获批,对吉利德LDV/SOF鸡尾酒疗法形成了直接威胁。

Daklinza/Sovaldi是一种每日一次、全口服、治愈率达100%的丙肝鸡尾酒疗法,为广泛基因型HCV丙肝患者提供了一种潜在治愈的治疗选择,包括一些难治性群体,如既往治疗失败的群体。

与Sovaldi一样,Daklinza与其他口服药物联合用药时,可排除常规注射制剂干扰素为基础的鸡尾酒方案。目前,在美国,吉利德Sovaldi是的统治者,而艾伯维(AbbVie)和默沙东(Merck Co)各自的全口服鸡尾酒疗法正在等待FDA的批准。

Daklinza是欧盟批准的NS5A复合体抑制剂,将与其他产品联用,提供一种较短治疗时间(12或24周)的治疗方案。而目前基于干扰素和利巴韦林(ribavilin)的治疗方案,治疗周期长达48周。Daklinza的获批,适用于欧盟所有28个成员国。此前,欧洲药品管理局人用医药产品委员会(CHMP)已授予Daklinza加速审批资格。

Dakllinza的获批,是基于数个研究的积极数据,包括一项开放标签、随机研究,调查了Daklinza+Sovaldi组合疗法治疗基因型1、2、3 HCV感染的疗效,包括对特拉匹韦(telaprevir)或boceprevir无反应及伴有肝纤维化的患者群体。数据表明,Daklinza+Sovaldi组合疗法在基因型1 HCV初治患者中的治愈率达到了99%,在既往对特拉匹韦或boceprevir治疗失败的基因型1 HCV群体中的治愈率达100%,在基因型2和基因型3 HCV中的治愈率分别为96%和89%.

此外,Daklinza治疗丙型肝炎的安全性,已在横跨各种不同群体中得到了证明,包括老年患者、伴有晚期肝病群体、肝移植后受者群体及HIV/HCV共感染群体。(生物谷)

英文原文:Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C

Want a window into the future of hepatitis C drug marketing? Keep an eye on Europe. Bristol-Myers Squibb bagged European approval for its hepatitis C fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to-head competition with Gilead Sciences' upcoming combo drug.

The EU nod covers Daklinza treatment in tandem with Gilead's Sovaldi (sofosbuvir), the heavyweight first entry in a new class of hep C drugs. If you haven't been on sabbatical, you know Sovaldi raged ahead to blockbuster status within one quarter on the market. You also know that Gilead ($GILD) is developing a Sovaldi combo pill, using its own ledipasvir as the companion ingredient--and that Gilead refused to team up with Bristol-Myers ($BMY) to study the Sovaldi-Daklinza combo, despite some eye-popping Phase II data.

Bristol-Myers is running those trials solo. And now, it can say the following in its EU approval press release: The Daklinza-Sovaldi cocktail is an "all-oral, once-daily regimen that yields cure rates of up to 100%.

百时美丙肝新药Daklinza获欧盟批准

" Plus, it "offers a potential cure" for a broad range of hep C patients, including some hard-to-treat groups, such as patients who've failed on previous therapies.

Like Sovaldi, Daklinza can squeeze out interferon-based treatment cocktails when combined with other oral meds. That's the promise of this new class: regimens that leave the difficult-to-tolerate interferon out. Right now, Sovaldi is the sole "nuc" in the U.S., but AbbVie ($ABBV) and Merck ($MRK) are looking for FDA approval for their own therapies.

And here's where it gets more interesting. We know Gilead will be leaning on its Sovaldi + ledipasvir pill, which is up for FDA approval by Oct. 10. AbbVie's three-drug option is under FDA review for a December decision. Bristol-Myers might want to tout the Daklinza + Sovaldi option when (and if) its FDA nod comes through in November.

But the FDA didn't allow the company to turn in that Sovaldi-Daklinza data with its current app. The approval would be for Daklinza and another BMS drug, Sunvepra (asunaprevir)--and that combo hasn't performed quite as well as the Daklinza-Sovaldi team in trials. Sustained virological response--a common measure in hep C trials--for the latter duo approached 100% in some patients, as Bristol-Myers noted in its EU announcement.

For the Daklinza-Sunvepra team, a recent trial showed response rates of up to 90%. That's way impressive--and gives the duo plenty of opportunity to score sales, as blockbuster analyst projections show. Company execs say the combo has been doing well in Japan, where it won approval in July. Plus, both of those drugs belong to Bristol-Myers, so the company would be collecting sales from two products, rather than one with the other combo. But what might Daklinza do with Sovaldi in the U.S.?

After Gilead spurned Bristol-Myers' offer to put Sovaldi alongside Daklinza in Phase III trials, the speculation was that doctors might prescribe the combo off-label, once the BMS drug won FDA approval. Right now, that prospect looks iffy. Payers are already setting up obstacles to expensive hep C treatments. Off-label use? Patients and doctors would have to jump through many hoops to get there, and physicians are already daunted by the work required to get FDA-approved regimens reimbursed, a recent Decision Resources survey found.

The market research firm also found that the hep C-treating specialists surveyed were more likely to know about Gilead's forthcoming combo pill than about Bristol-Myers and AbbVie's options. Half of those docs expect to prescribe Gilead's combination therapy within 6 months after approval and expect the combination of Sovaldi and Johnson Johnson's ($JNJ) protease inhibitor Olysio to hold its own. Sounds like Bristol-Myers and AbbVie's sales-and-marketing teams have their jobs cut out for them.

But here's the kicker: "[N]ear-term competitors that offer favorable pricing … will likely be a constraint on the uptake of [Gilead's] regimen," Decision Resources said. Which means that rivals that undercut Gilead's price might move ahead in the prescribing queue. AbbVie has said it's not interested in a price war. Maybe Bristol-Myers will be the one to step up.

:wn462

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