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Melinta近日宣布FDA批准了治疗由易感细菌引起的急性细菌性皮肤和皮肤结构感染的新药Baxdela(Delafloxacin)。Delafloxacin是一种氟喹诺酮,能对抗包括MRSA在内的革兰阳性和革兰阴性病原体。Delafloxacin新药申请(NDA)的批准得到了2个3期临床研究的支持,研究证明静脉注射或口服单疗法在FDA的48~72 h早期临床反应的主要终点上,并不亚于万古霉素和阿兹特龙的结合疗法。Delafloxacin有良好的耐受性,在3期临床中由不良反应而导致的终止率只有0.9%。
Melinta recently announced that the FDA has approved Baxdela (Delafloxacin), a new drug for the treatment of acute bacterial skin and skin structure infections caused by susceptible bacteria. Delafloxacin is a fluoroquinolone that works against gram-positive and gram-negative pathogens, including MRSA. The approval of the Delafloxacin New Drug Application (NDA) was supported by two phase 3 clinical studies demonstrating that intravenous or oral monotherapy was as subjective as the primary end point of the FDA’s early clinical response at 48-72 h, comparable to vancomycin and Azathlon combination therapy. Delafloxacin is well tolerated and has a termination rate of only 0.9% due to adverse effects in phase 3 clinical trials.