NRx Pharmaceuticals Gets FDA Review for Zyesami Manufacturing
NRx Pharmaceuticals Gets FDA Review for Zyesami Manufacturing
By Chris Wack
克里斯·瓦克(Chris Wack)著
NRx Pharmaceuticals Inc. said it received the U.S. Food and Drug Administration's response to its Oct. 8 submission of updated manufacturing information for Zyesami.
NRX制药公司(NRX PharmPharmticals Inc.)说，它收到了美国食品和药物管理局(FDA)对其10月8日提交的Zyesami最新生产信息的回应。
The company said the completion of this review, without the imposition of any clinical hold by the FDA, enables it to distribute Zyesami, produced at commercial scale, under Good Manufacturing Practices for clinical trials and other future purposes approved in future regulatory actions.
该公司表示，在FDA没有强制实施任何临床暂停的情况下完成这项审查，使其能够根据良好的制造规范(Good Manufacturing Practices)分销商业规模生产的Zyesami，用于临床试验和未来监管行动中批准的其他未来用途。
NRx said it is looking forward to working with the FDA to complete the chemistry, manufacturing, and controls review that will ultimately be required for any potential drug approval.
NRX表示，它期待着与FDA合作，完成任何潜在药物批准最终所需的化学、制造和控制审查。
Zyesami was previously manufactured for clinical trials purposes in handmade, 300 dose batches, with a limited shelf life of 62 days. The FDA has now reviewed a GMP manufacturing process at a batch size of 10,000--100,000 doses with a current shelf life of 150 days and identified no basis for a clinical hold.
Zyesami之前是为了临床试验目的而手工制造的，300剂批次，有限的保质期为62天。FDA现在已经审查了GMP的生产工艺，批量为10,000-100,000剂，目前的保质期为150天，但没有确定临床搁置的基础。
NRx Pharmaceuticals shares were up 7%, to $6.46, in premarket trading.
在盘前交易中，NRX制药公司的股价上涨了7%，至6.46美元。
Write to Chris Wack at chris.wack@wsj.com
写信给克里斯·瓦克(chris.wack@wsj.com)