Lilly's Heart Drug Snags Fast Track Designation; Type 2 Diabetes Drug Found Effective At Higher Doses

礼来心力衰竭治疗药物empagliflozin获FDA快速通道认定

2019-06-27 20:34:00 Benzinga

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Large-cap pharma Eli Lilly And Co has pulled back significantly from its late-March intra-day high of $132.13. The company issued updates on heart failure and diabetes drugs Wednesday.  Fast-Track Designation For Heart Failure Drug  Lilly said the FDA granted the Fast Track designation to empagliflozin, which is being evaluated for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure. Fast Track designation is accorded to develop new therapies that fill an unmet medical need for serious conditions to facilitate expeditious availability of new treatment options. The designation vests the advantages of more frequent meetings and correspondence with the FDA to discuss drug development; the scope for accelerated approval or priority review if requisite criteria are met; and eligibility for a rolling review. Empagliflozin, which goes by the trade name Jardiance, is co-developed by Lilly and the German pharma company Boehringer Ingelheim. The drug has already been approved as once-daily tablet for two indications: Type 1 diabetes and the reduction of cardiovascular death in adults with Type 2 diabetes. Heart failure contributes to one in nine deaths and is the leading cause of hospitalization in the U.S., but has limited treatment options, the companies said in a press release.  Empagliflozin is being evaluated in two Phase 3 studies dubbed EMPEROR. Diabetes Drug Aces Late-stage Trial  Lilly said a trial that evaluated higher investigational doses of Trulicity met its primary endpoint of superiority, significantly reducing A1C from baseline in people with Type 2 diabetes compared to once-weekly Trulicity 1.5mg after 36 weeks. Trulicity was first approved as once-daily subcutaneous injection along with diet and exercise by the FDA for Type 2 diabetes in 2014. The higher dose was tested in a Phase 3 study dubbed AWARD-11, which evaluated the safety and efficacy of 3mg and 4mg doses in 1,842 participants with Type 2 diabetes. Lilly shares were down 2.7% at $112.25 at the time of publication Wednesday. 
大型制药公司礼来公司( Eli Lilly and Co )已从3月下旬的盘中高点132.13美元大幅回落。 该公司周三发布了关于心力衰竭和糖尿病药物的最新信息。 心脏衰竭药物的快速指定 礼来(Lilly)说, FDA 批准了快速通道的指定,以 emphaliflozin ,这是正在评估减少心血管死亡风险和住院治疗心力衰竭患者。 快速跟踪指定是为了开发新的治疗方法,以满足未满足的医疗需要的严重条件,以促进迅速提供新的治疗选择。 指定的好处是更频繁的会议和通信与 FDA 讨论药物开发;范围加快批准或优先审查,如果必要的标准得到满足;和资格的滚动审查。 Empagliflozin 是由礼来(Lilly)和德国制药公司勃林格殷格翰(Boehringer Ingelheim)共同开发的,商品名为 Jardiance 。 该药物已被批准为每日一次的片剂,用于两个适应症:1型糖尿病和2型糖尿病成人心血管死亡的减少。 该公司在一份新闻稿中说,心力衰竭导致了9人中的1人死亡,是美国住院治疗的主要原因,但治疗选择有限。 Empagliflozin 正在被称为 EMPEOR 的两个第三阶段研究中进行评估。 糖尿病药物 Aces 后期试验 礼来(Lilly)说,一项评估较高研究剂量 Trulicity 的试验达到了其主要的优势终点,与每周一次的 Trulicity 1.5 mg 相比,2型糖尿病患者的 A1C 显著降低。 2014年, Trulicity 首次被 FDA 批准为每日一次皮下注射以及饮食和运动治疗2型糖尿病。 在一项名为 AWARD-11的第三阶段研究中测试了较高剂量,该研究评估了1842名2型糖尿病患者服用3mg 和4mg 剂量的安全性和有效性。 礼来(Lilly)公司股价周三下跌2.7%,至112.25美元。

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