赛诺菲糖尿病新药Lyxumia通过心血管安全性评价

赛诺菲糖尿病新药Lyxumia通过心血管安全性评价

  发布日期：2015-03-21  来源：生物谷

赛诺菲于周四宣布其糖尿病新药Lyxumia的三期临床试验结果，证明该药未发现心血管毒性。

赛诺菲于3月19日 宣布其糖尿病新药Lyxumia的三期临床试验结果，证明该药未发现心血管毒性。这个重要的结果将很大程度上促进监管部门对该药的审批。

Lyxumia，化学名为醋酸利西拉来，是GLP-1受体的激动剂，用于治疗II型糖尿病。GLP-1是一种餐后分泌天然存在的多肽激素，由于能加强机体自然产生胰岛素，该分子已成为糖尿病新药的靶点。这类药物已经在全球范围内在治疗糖尿病方面取得了突破性的进展。

在不断扩大的糖尿病药市场，GLP-1药物尤其是一直在上升。公司的直接竞争对手诺和诺德被认为是全球最大的胰岛素生产商，也在致力于开发GLP-1药物。诺和诺德也正在计划在期拳头产品Victoza之外，继续推出两个其它糖尿病领先产品用于继续加强其在GLP-1领域的影响力。赛诺菲预计可以在今年拿到Lyxumia的上市批准，看起来有希望与诺和诺德一争高下。

赛诺菲在Lyxumia获得FDA批准后在糖尿病市场上拥有很大优势，因为其三期临床试验ELIXA证明该药物无心血管毒性。ELIXA是赛诺菲开展的心血管安全性评估的随机双盲的临床研究。该试验招募了超过6000受试者，他们都是具有高心血管风险的II型糖尿病患者，近期都发生过急性冠脉事件。该试验已经达到了初步预期的结果，与安慰剂相比，Lyxumia没有增加心血管风险。药物被证明可以大大降低心血管死亡、非致死性心肌梗死以及非致死性中风。

赛诺菲全球研发中心主任Elias博士谈到该药在治疗糖尿病且没有引起心血管风险一事时说：“ELIXA试验的完成对Lyxumia来说一个里程碑，因为它是目前第一个可以长期用于高心血管疾病风险的糖尿病患者的GLP-1激动剂药物。”他补充到：“赛诺菲很气道将这些结果提交给世界的卫生组织。”

信源：bidness

生物谷推荐英文原文报道：

Sanofi SA (ADR)Reports Positive Cardiovascular Safety Results For Diabetes Drug Lyxumia

Sanofi SA (ADR)(NYSE:SNY) announced Thursday positive results for its diabetes drug Lyxumiafrom a Phase III study evaluating the cardiovascular risks of the said drug.The top-line results are expected to significantly expedite the regulatoryapproval of the treatment inside the US.

Lyxumia, also knownby its chemical name lixisenatide, works as a Glucagon-like peptide-1 (GLP-1)receptor agonist for treating adults suffering from type 2 diabetes, the mostcommon form of the debilitating disease. GLP-1, a naturally occurring peptidehormone, secreted soon after eating a meal, has opened doors for a new class ofdiabetes drugs which function by strengthening the body’s natural process ofproducing insulin. These GLP-1 drugs are bound to offer breakthrough treatmentoptions for a significantly large proportion of the world’s population livingwith the disease. In the ever-expanding diabetes drugs market, GLP-1 drugs haveespecially been on a rise, with the company’s direct rival Novo Nordisk A/S(ADR) (NYSE:NVO), considered to be the world’s largest insulin maker, alsoenhancing its focus on GLP-1 drugs. Novo, in addition to its blockbuster GLP-1treatment Victoza, is also planning to launch two other lead diabetes drugs tofurther strengthen its presence in the GLP-1 arena. Sanofi, with its GLP-1agonist Lyxumia expected to win US regulatory approval this year, looks ontrack to offer major competition to Novo’s diabetes business.

Diabetes currentlyaffects approximately 29 million or 9.3% of the people residing inside the US,of whom almost 90% are those living with type 2 form of diabetes. Diabetesdrugs business is going to be a top division at the French company if its newtreatment wins regulatory approvals as planned.

Sanofi looks to beat a significant advantage in the diabetes drugs market after Lyxumia rakes inthe final approval from the US Food and Drug Administration (FDA), which isexpected to come soon on the back of the positive results regarding the drug’scardiovascular risks revealed from a Phase IIIb study named ELIXA.

ELIXA, the firstever cardiovascular outcomes study carried out by the French drug-maker, was arandomized, double-blind trial with more than 6,000 study subjects, mainlyadults living with type 2 diabetes who were at a high cardiovascular risk,having suffered from "a spontaneous acute coronary syndrome event" inthe recent past. The study, comparing lixisenatide to a placebo, met theprimary endpoint establishing the drug’s significant efficacy in beingnon-inferior, although not superior, to the placebo for its cardiovascularrisks; the drug proved to considerably decrease the rates of cardiovasculardeath, non-fatal myocardial infarction, and non-fatal stroke. Dr. EliasZerhouni, President, Global R&D at Sanofi, said about the drug’s success intreating diabetes without posing major cardiovascular risks: “The completion ofthe ELIXA study is a significant milestone for lixisenatide, which is the firstGLP-1 receptor agonist with long-term cardiovascular safety data in people withdiabetes who have high cardiovascular risk.”

"Sanofi looksforward to submitting the results to health authorities worldwide," headded, as per the press release made by the company today.

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