百时美施贵宝抗HIV新药Evotaz获FDA批准

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近日，百时美施贵宝宣布其新药 Evotaz获FDA批准， Evotaz 是atazanavir、cobicistat和其它抗病毒药的固定剂量复方制剂，用于治疗成人艾滋病。

Evotaz为片剂，用法是每日一次，由300mg的 atazanavir（一种蛋白酶抑制剂，以商品名Reyataz 单独销售）、150mg的 cobicistat（据称是一种“增强药代动力学”的药物，目前由吉利德以商品名Tybost销售）组成。

Evotaz获批对HIV感染者而言是一个好消息。据悉每年约有50000人感染HIV而导致获得性免疫缺陷综合征（AIDS）。目前美国的HIV感染者约为110万人，而大多数患者对治疗有耐药性，因此需要新的治疗方法来抑制病毒。

FDA批准Evotaz是基于称为114号研究的3期临床试验的阳性结果。该双盲试验比较了300mg Reyataz+150mg cobicistat (即Evotaz)和300mg Reyataz+100mg  ritonavir 的效果。48周治疗后，服用Evotaz的病人中85%的HIV-1 RNA水平低于50个拷贝/ml，与对照组Reyataz/ritonavir的87%消退率相比是不分伯仲。此外，Evotaz作为蛋白酶抑制剂单独使用时抗病毒的失效率低于6%，与cobicistat联用后，失效率就降到最低。

最重要的是，临床试验结果表明48周后病人的耐药性为零，单独用tenofovir无耐药性，而当用Evotaz 后病人表现出对 emtricitabine有耐药性。但是总体而言，3期临床结果表明了 Evotaz的有效性和安全性。

百时美施贵宝的全球市场总管Murdo Gordon表示， 百时美很高兴能为全球AIDS患者提供新的治疗方法，atazanavir与cobicistat 联用能维持48周以上安全、有效的治疗。

此番Evotaz获批标志着一个开创性的治疗方式。然而，Evotaz和Reyataz并不代表能完全治愈HIV-1感染造成的AIDS。并且那些接受 Evotaz 治疗的患者此前也接受过其他的抗病毒治疗，一定程度上已经获得了蛋白酶抑制剂治疗的耐药性“基线”水平。此外对Evotaz任意一种成分过敏的患者也不能用药。

Evotaz获批是百时美施贵宝努力了20年的结果，这次也表明百时美对HIV药物的研发水平已经上了一个新台阶。

这次获批对百时美和吉利德的合作也是个好消息，2011年两家公司就atazanavir 和cobicistat的固定剂量复方制剂的研发和销售事宜签署协议，协议表明百时美具有产品的生产、注册、分销和商品化等权利，而吉利德承担cobicistat 的生产、研发和销售工作。

当然，Evotaz获批对百时美而言意味着巨大的经济效益，2015年以及相当一段时间内百时美都会受益不匪，同时，随着Evotaz获批，百时美的股价也会随之上涨。

原文 Bristol-Myers Squibb Co (BMY) HIV-1 Combo Drug Gets FDA Nod

Bristol-Myers Squibb Co (NYSE：BMY) announced Thursday that the US Food and Drug Administration (FDA) has approved its drug Evotaz as a fixed-dose combination of atazanavir， cobicistat， and other antiretroviral agents to treat adult patients with human immunodeficiency virus (HIV-1).

Evotaz is a single pill， used once daily， formed by combining 300 mg of atazanavir， a protease inhibitor which is sold as a single agent in Reyataz capsules， with 150 mg of cobicistat， a “pharmacokinetic enhancer” currently sold by Gilead Sciences， Inc. (NASDAQ：GILD) under the name Tybost.

The drug’s approval comes as good news for HIV patients. Approximately 50，000 new cases are reported every year of HIV， an infection which leads to acquired immune deficiency syndrome (AIDS) in the long term. The virus currently affects almost 1.1 million people in the US. Most patients diagnosed with HIV are resistant to the treatments they receive， signifying a strong need for novel treatments that could help suppress the virus.

The FDA approved Evotaz on the back of positive results from the drug’s Phase III trial called Study 114. The randomized， double-blind study compared the efficacy of the Reyataz 300 mg and cobicistat 150 mg combination (Evotaz) to the Reyataz 300 mg and ritonavir 100 mg combination； ritonavir was also used as a pharmacokinetic-enhancing agent. After a duration of 48 weeks， 85% of the patients administered with Evotaz showed HIV-1 RNA levels of <50 copies/mL versus 87% of patients in the Reyataz/ritonavir arm. Additionally， the significantly lower virologic failure rates of lesser than 6% established Evotaz as the sole protease inhibitor that has shown the lowest virologic failure rate when used with cobicistat.

Most importantly， the results of the clinical trial showed zero resistance of protease inhibitors in patients after 48 weeks. There was no resistance for tenofovir， while only patients given Evotaz were shown to develop resistance for emtricitabine. Overall， the Phase III trial demonstrated significant efficacy and safety of Evotaz.

Murdo Gordon， head of Worldwide Markets at Bristol-Myers Squibb， said about the approval： “We are pleased to provide physicians and patients with an important new option to treat HIV； atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks， as demonstrated through its rigorous clinical development plan， including a head-to-head Phase III trial.”

The approval signifies Evotaz as a ground-breaking treatment， showing proven viral suppression (HIV-1 RNA <50 copies/mL， 85% Evotaz arm； 87% Reyataz/ritonavir arm) in a 48-week time frame. However， Evotaz and Reyataz do not offer complete cure for HIV-1 and AIDS. Also， patients who have already received any HIV treatment prior to Evotaz have to get their “baseline” level of resistance analyzed for protease inhibitors. Furthermore， Evotaz is also contraindicated for those patients who have shown high clinical “hypersensitivity” to any regimen in the product.

Evotaz’s approval follows 20 years’ worth of dedicated efforts by the company to bring significant treatments for the HIV community. With the recent approval， Bristol-Myers Squibb is now in a position to further strengthen its R&D efforts for innovative treatments for HIV patients worldwide.

The approval also bodes well for the licensing agreement between Bristol-Myers Squibb and Gilead signed in October 2011， pertaining to the development and marketing of the fixed-dose combination of atazanavir and cobicistat. The deal gave the rights of manufacture， registration， distribution， as well as commercialization of the product to Bristol-Myers Squibb， while Gilead was given the responsibility to manufacture， develop， and commercialize the cobicistat regimen.

The FDA approval of Evotaz is expected to bring in high revenue for Bristol-Myers Squibb， ensuring solid performance for the company in 2015 and beyond. The company’s stock price， on the back of the positive news， is expected to rise when trading resumes Friday.