Business
NRx Pharmaceuticals Announces Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)
RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), today announced that a revised Investigational New Drug module on the
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), today announced that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of the FDA's rolling review process supporting the New Drug Application for ZYESAMI. \n\n \n \n \n \n \n \n\n \nAs thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval,\" said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. NRx awaits a QP Declaration that is required by the EU regulatory authorities for the release of ZYESAMI. The audit was completed in preparation for submission of European Union (EU)-standard ZYESAMI to EU and United Kingdom health regulatory authorities. Under EU law, a QP Auditor is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU or imported into the EU.\n\"As thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval,\" said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.\nAbout ZYESAMI™/VIP in COVID-19Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfac...