在 3 期试验结果积极后,英国 MHRA 批准 Cidara 的 REZZAYO 用于成人侵袭性念珠菌病治疗。 UK's MHRA approves Cidara's REZZAYO for adult invasive candidiasis treatment, following positive Phase 3 trial results.
Cidara Therapeutics 宣布,英国药品和保健品监管局 (MHRA) 已批准 REZZAYO(醋酸瑞扎芬净)治疗成人侵袭性念珠菌病。 Cidara Therapeutics announced that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate), their treatment for invasive candidiasis in adults. 在此之前,ReSTORE 3 期临床试验取得了积极的结果。 This follows positive results from the ReSTORE Phase 3 clinical trial. Cidara 与 Mundipharma 合作,后者拥有瑞扎芬净在美国和日本以外的商业权利。 Cidara has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. 该公司有权获得 MHRA 批准的 280 万美元付款。 The company is entitled to receive a $2.8 million payment for the MHRA approval.