– NRx Pharmaceuticals requested a Type A meeting with the US Food and Drug Administration (FDA) to include referring physicians and patients
– The FDA commits to work with NRx to develop ZYESAMIÂ®
– ZYESAMI clinical trials funded by the US National Institutes of Health and BARDA continue and move towards recruitment in Brazil and Europe
RADNOR, Pennsylvania., November 4, 2021 / PRNewswire / – NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company (NRx), today announced that the United States Food and Drug Administration (FDA) has refused to issue an Emergency Use Authorization (EUA) for ZYESAMIÂ® (aviptadil). The FDA has said it is unable to issue EUA at this time due to insufficient data regarding the known and potential benefits of the drug and the known and potential risks of ZYESAMI in patients with COVID-19. critical with respiratory failure. In its letter, the FDA noted that to date it has only reviewed for safety in 131 randomized patients treated with ZYESAMI. NRx will attempt to coordinate an FDA review of the additional 150 or more patients already treated with ZYESAMI in the NIH ACTIV-3b trial. Last week, the study’s Data Safety and Surveillance Committee reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.
âYesterday, more than 1,500 Americans and many more around the world died a solitary death from COVID-19, isolated from loved ones in intensive care units despite widespread vaccination and approved treatments currently available,â said Jonathan javitt, MD, MPH, CEO and Chairman of the Board of NRx. âWe believe that ZYESAMI has demonstrated a high level of safety and a doubling of the chances of survival in the ICU. Patients treated in the best hospitals in the country with ZYESAMI have quadrupled their chances of survival. We will actively work with the FDA to provide the data it has requested so that we can give these patients another chance at life, and have requested the FDA for a Type A meeting that will include the experience of physicians who have been witness the effects of our medicine firsthand and the experience of patients who are alive today because they had one last chance to live. In the meantime, we are actively engaged with regulators and potential partners on multiple continents to move ZYESAMI towards regulatory approval. Now that we have completed the chemical and manufacturing controls (CMC) required for traditional approval pathways, we will move towards filing for expedited approval based on the surprisingly strong biomarker results observed in our two cl trials. iniquitous. “
Last week, NRx called for a Type A meeting with FDA officials, a request approved by the study’s lead investigators, to discuss the development of ZYESAMI. In the meantime, ZYESAMI remains available upon request by a physician under federal and state Right to Try laws for patients who meet the legal criteria for the Right to Try.
The US National Institutes of Health enrolled more than 300 patients in the ACTIV-3b trial. a confirmatory study that randomizes patients with COVID-19 respiratory failure to ZYESAMIÂ® against VekluryÂ® (remdesivir) and placebo in a factorial design trial (NCT04843761). A second national trial to determine whether similar benefits can be achieved in critically ill patients with inhaled ZYESAMI is underway on the I-SPY platform, managed by the Quantum Leap Healthcare Collaborative. This week, the Data Safety Monitoring Board of the NIH ACTIV-3b trial reported that no new serious drug-related adverse events were observed and approved the trial for further recruitment. NRx is also continuing to study the effect of inhaled ZYESAMI in patients with severe but non-critical COVID-19 in a placebo-controlled trial that aims to demonstrate the ability of ZYESAMI to prevent patients from requiring intensive care.
About NRx Pharmaceuticals
NRx Pharmaceuticals (NRx) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. Its investigational product, ZYESAMIÂ® (aviptadil) for patients with COVID-19, has received Fast Track designation from the United States Food and Drug Administration (FDA) and is currently in phase 3 funded trials. by the United States National Institutes of Health, the Biomedical Advanced Research and Development Authority which is part of the United States Department of Health and Human Services, and the Medical Countermeasures Program, which is part of the United States Department of Defense . The FDA further granted a breakthrough therapy designation, a special protocol agreement, and a letter of biomarker support to NRx for NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in phase 3 trials, with readings expected in 2022. In July 2021, the government of Israel granted NRx the exclusive worldwide right to develop and market the BriLife â¢ COVID vaccine developed by the Institute. Israeli biological research.
NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is chaired by Professor Jonathan Javitt, MD, MPH, who has held leadership positions in six biotech startups with public outings and has been appointed to advisory roles in four US presidential administrations. NRx’s board of directors includes Dr Sherry Glied, former US Assistant Secretary of Health (ASPE), Daniel E. Troy, JD, former US FDA legal counsel, Chaim Hurvitz, former director of Teva and President of Teva International Group; and General HR McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.
Caution regarding forward-looking statements
This announcement by NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our outlook, product development, business outlook and market and industry trends and conditions, as well as company strategies, plans, objectives and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts and projections, as well as on assumptions made by the management of the company and on information currently available to the company.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Therefore, you should not rely on any forward-looking statements, and all forward-looking statements are qualified herein by reference to the cautionary statements set forth above.
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