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製藥公司(NRX PharmPharmticals Inc.)説，它收到了美國食品和藥物管理局(FDA)對其10月8日提交的Zyesami最新生產信息的迴應。
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.
該公司表示，在FDA沒有強制實施任何臨牀暫停的情況下完成這項審查，使其能夠根據良好的製造規範(Good Manufacturing Practices)分銷商業規模生產的Zyesami，用於臨牀試驗和未來監管行動中批准的其他未來用途。
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，它期待着與FDA合作，完成任何潛在藥物批准最終所需的化學、製造和控制審查。
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之前是為了臨牀試驗目的而手工製造的，300劑批次，有限的保質期為62天。FDA現在已經審查了GMP的生產工藝，批量為10,000-100,000劑，目前的保質期為150天，但沒有確定臨牀擱置的基礎。
NRx Pharmaceuticals shares were up 7%, to $6.46, in premarket trading.
在盤前交易中，NRX製藥公司的股價上漲了7%，至6.46美元。
Write to Chris Wack at chris.wack@wsj.com
寫信給克里斯·瓦克(chris.wack@wsj.com)