The company ‘NRx Pharmaceuticals’ has announced the results of the review conducted by the US FDA to the submission of the updated manufacturing information of the ZYESAMI (aviptadil) of the NRx Pharmaceuticals.
The completion of the review from the US FDA without any of the imposition of any kind of the clinical hold has been responsible for enabling the NRx Pharmaceuticals for distributing the ZYESAMI, which has been manufactured at the commercial scale, under the Good Manufacturing Practices (GMP) for all the clinical trials and several other purposes that are going to be approved in the further regulatory actions.
The company NRx has also been looking forward to working with the US FDA for the process of completing the review of the chemistry, manufacturing and controls (CMC) that is ultimately going to be required for any of the potential approval of the drug. Prior to the novel corona virus pandemic, the ZYESAMI had been never manufactured being as a commercial drug for the intravenous use.
Between the month of March and May 2020, the NRx Pharmaceuticals has now formulated the vaccine, which has been based on the files of the history and also initiated the phase 2 clinical trial approved by the US FDA by producing ZYESAMI in an 503b pharmacy, which has been inspected by the US FDA.
Prof. Jonathan Javitt, chairman and CEO of NRx Pharmaceuticals said, this review of US FDA has been representing the first time aviptadil, which has been manufactured in an commercial GMP environment inspected by US FDA for an inhaled and intravenous use and has also passed the regulatory review of the CMC and manufacturing.