FDA给予Cidara的非疫苗流感药物突破性地位,在试验中保护率为58%-76%。
FDA grants breakthrough status to Cidara’s non-vaccine flu drug, showing 58%-76% protection in trials.
美国食品和药物管理局已授予CD388的突破性治疗指标,这是Cidara Therapeutics开发的非疫苗流感预防研究药物.
The FDA has granted breakthrough-therapy designation to CD388, an investigational non-vaccine flu preventive developed by Cidara Therapeutics.
CD388是一种长效抗病毒药物,不依赖免疫系统,是为严重流感风险较高的成人和青少年设计的。
Designed for adults and adolescents at higher risk of severe flu, CD388 is a long-acting antiviral drug that does not rely on the immune system.
根据第2b阶段的试验结果,该试验显示,在6个月的时间里,58%至76%的季节性流感保护。
Based on Phase 2b trial results, it showed 58% to 76% protection against seasonal influenza over six months.
该药物现已进入第3阶段试验,Cidara从卫生与公众服务部获得多达3.39亿美元的资金,用于支持发展。
The drug is now in a Phase 3 trial, with Cidara receiving up to $339 million in funding from the Department of Health and Human Services to support development.