5 New HCV Drugs in Phase 3 Now

StephenW

http://www.natap.org/2012/HCV/082912_01.htm
5 New HCV Drugs in Phase 3 Now


      
BMS052 HCV-NS5A Monotherapy in Phase 3 Now

GS-7977 HCV Nucleotide in Phase 3 Now

Peginterferon Lambda: new interferon in phase 3 now

BI1335 HCV Protease in Phase 3 Now

TMC-435 HCV Protease in Phase 3 -

"Rapid progress has been made with the HCV Research Program and we now have a comprehensive Phase III development program" John Martin CEO Gilead........"In May and June of this year, discussions were held with the U.S. FDA and 3 European regulatory agencies, and agreement has been achieved on a comprehensive Phase III development plan for GS-7977 and on a Phase III plan for GS-7977 in combination with the NS5A inhibitor, GS-5885.......we anticipate being able to file for regulatory approvals for GS-7977 by the middle of next year.......If successful, the initial indication will for 12 to 16 weeks of treatment with GS-7977 and Ribavirin in genotype 2/3 infected patients, and for 12 weeks of treatment with GS-7977, peg-interferon and Ribavirin in genotype 1, 4, 5 and 6 infected patients......we plan to advance the fixed dose combination of GS-7977 and 5885, currently in Phase I clinical testing, into Phase III in the fourth quarter of this year.....GS-7977 and GS-5885 were successfully co-formulated into a single pill, fixed dose combination......The fixed dose combination regulatory filings could, in that case, follow the initial GS-7977 filings a year later by mid-2014"....."The Food and Drug Administration is allowing a nonstandard-of-care controlled phase III study for 7977/5885" from Barron's online [we know the FDA is allowing this for all IFN-free therapy development studies from all companies]

在第3阶段现在的5个新的HCV药物


  
在第3阶段现在BMS052 HCV-NS5A单药治疗

GS-7977丙型肝炎病毒核苷酸现在在第3阶段

聚乙二醇干扰素拉姆达：新现在在第3阶段

BI1335现在在第3阶段的丙型肝炎病毒蛋白酶

TMC-435丙型肝炎病毒蛋白酶在第3阶段 -

“快速进步已与丙型肝炎病毒的研究计划，现在我们有一个全面的第三阶段发展计划”首席执行官约翰·马丁（John Martin）基列......“在今年五月和六月，讨论了与美国FDA召开和3个欧洲监管机构和协议已经实现了全面的第三阶段发展计划GS-7977和第三阶段的计划GS-7977结合NS5A抑制剂，GS-5885.......我们能够预测到明年年中提交监管部门的批准GS-7977......如果成功的话，最初的迹象GS-7977和利巴韦林治疗12〜16周的基因型2/3感染的患者，和12周的治疗，GS-7977，PEG-干扰素和利巴韦林基因型1，4，5和6感染的患者......我们计划提前GS-7977和5885的固定剂量复方制剂，目前在I期临床试验，进入第三阶段在今年第四季度..... GS-7977，GS-5885的成功合作制定的固定剂量组合成一个单一的药片，......“在这种情况下，固定剂量复方提交给监管机构的文件，按照最初的GS-7977申请一年后的2014年中期“.....”美国食品和药物管理局（FDA）允许非标准的护理的对照III期研究5885分之7977“从巴隆在线[我们知道，美国食品药品管理局允许所有公司所有IFN-免费治疗发展研究]

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