Alkermes递交抗精神分裂症药物aripiprazole lauroxil新药申请

Alkermes递交抗精神分裂症药物aripiprazole lauroxil新药申请

                               
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发布日期：2014-08-28  来源：zacks  

总部位于爱尔兰的生物制药公司Alkermes近日已向美国食品药品监督管理局（FDA）递交了aripiprazole lauroxil用于治疗精神分类症的新药申请

                               
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总部位于爱尔兰的生物制药公司Alkermes近日已向美国食品药品监督管理局（FDA）递交了aripiprazole lauroxil用于治疗精神分类症的新药申请（new drug application，NDA）。aripiprazole lauroxil是一种新型在研的、每月一次的长效非典型抗精神病注射剂。

此次NDA是基于一项旨在评价aripiprazole lauroxil有效性和安全性的随机、多中心、双盲、安慰剂对照的III期临床试验的积极数据，临床数据显示与安慰剂相比，aripiprazole lauroxil可明显改善精神分裂症的症状。

“Alkermes所研发的aripiprazole lauroxil有别于其他抗精神分裂症药物，aripiprazole lauroxil拥有随时可供使用的多个剂量选择方案，有助于满足患者和医护人员不同的个体化需求。”公司首席执行官Richard Pops讲到，“aripiprazole lauroxil的以上特点以及先期试验显现的强有力的临床数据，使得该药成为不断增长的长效注射抗精神病药物市场中的一个有意义的新参与者。

我们期待与FDA共同合作，尽快将这一重要的新药推向患者和医生。”

III期临床试验中，aripiprazole lauroxil的两种给药剂量（441mg和882mg）均每月给药一次，与安慰剂相比，两种剂量都达到了主要终点和次要终点，同时显著改善了精神分裂症的症状。

Alkermes Gains on Aripiprazole Lauroxil NDA Submission - Analyst Blog

Alkermes ( ALKS ) submitted a New Drug Application (NDA) for aripiprazole lauroxil in the U.S. The company is looking to get aripiprazole lauroxil approved for the treatment of schizophrenia. Alkermes shares gained almost 2.3% on the news.   

The company's regulatory submission included results from the pivotal phase III study on the efficacy and safety of aripiprazole lauroxil. The randomized, multicenter, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the candidate (once a month) across two doses (441 mg and 882 mg) in patients with acute exacerbation of schizophrenia.

Results revealed statistically and clinically significant reduction in patients' total scores compared to placebo on the Positive and Negative Syndrome Scale following 12 weeks of treatment with aripiprazole lauroxil across both the evaluated doses. Moreover, the candidate showed significant improvements in schizophrenia symptoms in comparison to placebo. Aripiprazole lauroxil was also well tolerated during the study.

We are encouraged by Alkermes' progress with aripiprazole lauroxil. Alkermes is also evaluating aripiprazole lauroxil for a once every two months dose. The candidate will enter a lucrative schizophrenia market on approval which is expected to boost Alkermes' top line. As per National Institutes of Health (as of Aug. 22, 2014) there are around 2.4 million adults in the U.S. suffering from schizophrenia. However, the schizophrenia market currently has companies like Novartis ( NVS ) and Eli Lilly and Company ( LLY ).

Alkermes, a biopharmaceutical company, carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care space is Gilead Sciences ( GILD ) sporting a Zacks Rank #1 (Strong Buy).

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