Actelion上周宣布，FDA已授予新型抗生素cadazolid合格传染病产品（QIDP）认定和快速通道地位，该药开发用于难辨梭状芽孢杆菌相关性腹泻（CDAD）的治疗。
QIDP认定意味着，在成功完成正在开展的全球性III期IMPACT项目后，cadazolid将获得优先审查权。而快速通道地位旨在促进FDA和制药公司在药物开发上的沟通和协作。
QIDP是2012年7月美国《FDA安全与创新法案》（FDA Safety and Innovation Act）下GIAN法案产生的新药特批通道，旨在激励抗生素研发，以应对严重威胁生命的细菌感染。简单地说，QIDP=研究阶段快速通道（fast track）+审批阶段优先审评（priority review）+上市后5年额外市场独占权。
关于
cadazolid是一种新型抗生素，是难辨梭状芽孢杆菌（Clostridium difficile）蛋白质合成强有力抑制剂，能够强烈抑制毒素生成和孢子形成。在临床前研究中，cadazolid对难辨梭状芽孢杆菌临床分离株具有强劲的体外活性，同时具有很低的抗性形成倾向。在人体肠道CDAD模型中，cadazolid对肠道微生物群落的影响非常有限。
Actelion's novel antibiotic cadazolid receives US FDA Qualified Infectious Disease Product designation for the treatment of Clostridium difficile-associated diarrhea
ALLSCHWIL/BASEL, SWITZERLAND - Actelion Ltd (six:ATLN) today announced that the US Food and Drug Administration (FDA) has designated cadazolid as both a Qualified Infectious Disease Product (QIDP) and a Fast Track development program for the treatment of Clostridium difficile-associated diarrhea (CDAD).
The QIDP designation for cadazolid means that - among other incentives - cadazolid would receive a nine-month priority review upon successful completion of the ongoing global Phase III IMPACT program. The Fast Track designation is intended to promote communication and collaboration between the FDA and the Company on the development of the drug.
The designations are based on the 2012 US Generating Antibiotic Incentives Now (GAIN) Act. The GAIN act is a legislative effort to incentivize the development of new antibiotic agents that target serious life-threatening infections.
Guy Braunstein, M.D. and Head of Clinical Development commented: "Clostridium difficile-associated diarrhea is a very serious and potentially life-threatening infection. There is a great need for an antibiotic that allows effective treatment of CDAD with low recurrence rates, particularly in infections caused by hypervirulent strains. The GAIN act highlights the importance of research in this area and we are very happy to receive the advantages that this designation for cadazolid will afford us."
ABOUT THE IMPACT PROGRAM
IMPACT is an International Multi-center Program Assessing Cadazolid Treatment in patients suffering from Clostridium difficile-associated diarrhea (CDAD). The program comprises two Phase III studies comparing the efficacy and safety of cadazolid (250 mg administered orally twice daily for 10 days) versus vancomycin (125 mg administered orally four times daily for 10 days).
The IMPACT studies are designed to determine whether the clinical response after administration of cadazolid is non-inferior to vancomycin in subjects with CDAD, and whether administration of cadazolid is superior to vancomycin in the sustained clinical response. The program is expected to enroll approximately 1'280 subjects worldwide, and commenced enrollment in the fourth quarter of 2013.
ABOUT CADAZOLID
The novel antibiotic cadazolid is a strong inhibitor of Clostridium difficile protein synthesis leading to strong suppression of toxin and spore formation. In preclinical studies cadazolid showed potent in vitro activity against Clostridium difficile clinical isolates and a low propensity for resistance development. In a human gut model of CDAD, cadazolid had a very limited impact on the normal gut microflora.
Cadazolid absorption is negligible resulting in high gut lumen concentrations and low systemic exposure, even in severe cases of CDAD where the gut wall can be severely damaged and permeability to drugs potentially increased.
ABOUT CADAZOLID IN THE PHASE II STUDY
Cadazolid was studied in a Phase II multi-center, double-blind, randomized, active reference, parallel group, therapeutic exploratory study. The study evaluated the efficacy, safety and tolerability of a 10-day, twice daily oral administration of 3 doses (250 mg, 500 mg or 1,000 mg b.i.d.) of cadazolid in subjects with Clostridium difficile-associated diarrhea (CDAD). As the current standard of care for CDAD, oral vancomycin (125 mg qid for 10 days) was used as the active reference. The study was completed in December of 2012, after having enrolled 84 subjects with CDAD.
The results of the Phase II study indicate that the effect of all doses of cadazolid were numerically similar to, or better than vancomycin on key endpoints including CDAD clinical cure rates as well as sustained cure rates. Clinical cure rate was defined as the resolution of diarrhea and no further need for CDAD therapy at test-of-cure 24 to 72 hours after the last dose of treatment, while sustained cure rate was defined as clinical cure with no recurrence of CDAD up to 4 weeks post-treatment. Recurrence rates were numerically lower for all doses of cadazolid as compared to vancomycin. Cadazolid was safe and well tolerated.
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