An estimated 2000 individuals in the United States are living with PH1, which is a progressive metabolic disorder that primarily affects the kidneys and can lead to worsening kidney damage. The FDA approval was based on the results of the pivotal, randomized, double-blind phase 2 PHYOX2 clini...
Nedosiran 从首次 IND 申请到获批上市历时约 6 年时间,支持 Nedosiran 首次 NDA 批准的主要临床试验包含 1 项Ⅰ期试验、1项 Ⅱ 期试验 1 项Ⅲ 期临床试验。 FDA 基于Ⅱ 期临床试验(PHYOX2)和Ⅲ 期临床试验(PHYOX3)扩展研究的中期数据批准上市。PHYOX2 是一项关键性、随机、双盲试验,比较了 Nedosiran 和...
"The FDA approval of Rivfloza builds on Novo Nordisk's legacy of advancing research, fostering innovation and creating strategic partnerships to expand treatment options in rare diseases," said Blandine Lacroix, Senior Vice President, Strategy and Rare Disease at Novo Nordisk Inc. "We are committed...
The ILLUMINATE-A trial of lumasiran in patients with primary hyperoxaluria type 1 supported the FDA approval of this drug. February 27th 2021 Nedosiran explored in primary hyperoxaluria type 3 Jason M. Broderick The RNAi drug nedosiran is a once-monthly subcutaneous injection under investigation for...
Clinical research on nedosiran has progressed through various phases, culminating in its FDA approval. The PHYOX clinical trial program has been instrumental in demonstrating the drug's efficacy and safety. The phase 1 PHYOX1 trial (NCT03392896) showed promising results, with a mean maximal reducti...