Clinical NRx Pharma's ZYESAMI™ approved for emergency use Covid critical...

NRx Pharma’s ZYESAMI™ approved for emergency use Covid critical care in Georgia


As of July 27, a global biopharmaceutical company, NRx Pharmaceuticals, has announced that the Prime Minister of the Nation of Georgia, together with the Health Minister, have issued an Emergency Use Authorization (EUA) for injecting ZYESAMI (aviptadil) as a treatment for critical COVID-19 condition.
“Lead investigators from our ZYESAMI clinical trials are on their way to the Nation of Georgia and will be on the ground there within 24 hours to start teaching physicians how to administer ZYESAMI™ to some of the sickest of COVID patients,” said Prof. Jonathan Javitt, MD, MPH, Chief Executive Officer and Chairman of the Board of NRx. “The repeating ferociousness of this pandemic is of great concern, and we hope ZYESAMI™ can have a real-world impact, comparable to what we saw in our clinical trials.”
A significant increase in the COVID-19 cases on daily basis ̶ hospitalization of patients, especially in the hospital ICUs ̶ as seen by the doctors of Georgia, has led to the approval of the drug by the regulatory authority.
Dr. Ivane Chkhaidze, a leading pulmonary physician in Georgia and a member of the Association of Georgia Physicians Leadership Team, said, “This latest wave of COVID-19, brought on by the delta variant has medical professionals in Georgia working throughout each day and night trying to keep people breathing.” He further added, “We appreciate the Prime Minister and Minister of Health authorizing the use of ZYESAMI and offering Georgian physicians a new treatment to help people recover from this devastating virus.”
A team of physicians traveling to Georgia to train fellow doctors about the effects and administration of the drug, is headed by Dr. Javier Perez-Fernandez, a lead investigator in the Phase 2b/3 clinical trial of intravenous ZYESAMI, and critical care pulmonologist in Miami, Florida. 20 of the leading critical care physicians in the country are in the team of Georgian physicians who got trained first.
Initial doses of ZYESAMI™ will arrive within 24 hours in the Nation of Georgia. The discussions regarding the provision of the drug for the critical COVID-19 Georgian patients, are still undergoing with the Ministry of Health.

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