Four US Senators have written a letter to Drs. Califf and Fauci requesting information on why Zyesami has not been approved. Although Leronlimab was not mentioned, parts of their letter are applicable. The website is wispolitics.com (Sen Johnson, one of the authors, represents Wisconsin). This is not intended as FUD - they are asking some good questions which apply to Leronlimab as well. One could at least hope that it pushes the FDA to develop a new mindset re Covid treatments. Note that they point out the review process appears to favor large manufacturers. If any of you live in states which those senators represent (Wisconsin, Texas and Arizona), perhaps you could write them about Leronlimab.
I will post some excerpts and the link below.
We are writing regarding a recent report of a physician practicing in Texas who has used a treatment—ZYESAMI—under the Right to Try Act to save COVID-19 patients’ lives.[1] Our understanding is the drug manufacturer, NRx Pharmaceuticals, applied for three Emergency Use Authorization’s (EUA) with the Food and Drug Administration (FDA) for ZYESAMI. NRx submitted its most recent EUA application on January 4, 2022 but the FDA has not yet granted this authorization. However, we are told the FDA refuses to review the data until the completion of clinical trials later this year.[2] We write to request information on the FDA’s review of ZYESAMI, as well as other information about treatment options for Americans suffering from COVID-19.
We are grateful to hear of patients successfully receiving lifesaving treatment under Right to Try. However, we are concerned that the FDA, National Institute of Allergy and Infectious Diseases (NIAID) and other public health agencies are not doing all they can to make this promising treatment available to Americans suffering from COVID-19. Almost a year ago, Dr. Fauci touted ZYESAMI as a promising treatment for COVID-19.[8] However, the drug remains largely unavailable, and we are told FDA refuses to review the data of NRx’s EUA until the National Institute of Health (NIH) completes clinical trials of ZYESAMI later this year.[9]
Two years into a pandemic and with a death toll exceeding a reported 900,000 Americans, it is unacceptable that the FDA and NIAID are needlessly delaying a treatment for late-stage COVID-19 with a remarkable track record of success. This bureaucratic dragging of your feet appears in stark contrast to the expedited review of other treatments like remdesivir, Molnupiravir, Paxlovid and the COVID-19 vaccines. The FDA’s disparate review processes for different treatments that appears to favor large manufacturers is troubling.
To better understand the FDA’s decisions regarding an EUA for ZYESAMI, we respectfully request the following information:
1. Please provide a timeline of FDA and NIAID actions to review ZYESAMI as an emergency treatment for COVID-19.
2. Please provide documentation of any communications between FDA or NIAID and physicians or hospitals that are utilizing ZYESAMI under Right to Try.
3. Has the FDA ever accepted the data of ongoing clinical trials when issuing an EUA for a treatment for COVID-19? If so, please provide the treatment and its EUA.
4. Please explain why the FDA refuses to review ZYESAMI data until completion of a clinical trial.
5. For COVID patients that received remdesivir and steroids but did not recover, what is the FDA and NIAID’s current treatment recommendation?
https://www.wispolitics.com/2022/u-s-sen-john...HZ8uvMV4Ao
I will post some excerpts and the link below.
We are writing regarding a recent report of a physician practicing in Texas who has used a treatment—ZYESAMI—under the Right to Try Act to save COVID-19 patients’ lives.[1] Our understanding is the drug manufacturer, NRx Pharmaceuticals, applied for three Emergency Use Authorization’s (EUA) with the Food and Drug Administration (FDA) for ZYESAMI. NRx submitted its most recent EUA application on January 4, 2022 but the FDA has not yet granted this authorization. However, we are told the FDA refuses to review the data until the completion of clinical trials later this year.[2] We write to request information on the FDA’s review of ZYESAMI, as well as other information about treatment options for Americans suffering from COVID-19.
We are grateful to hear of patients successfully receiving lifesaving treatment under Right to Try. However, we are concerned that the FDA, National Institute of Allergy and Infectious Diseases (NIAID) and other public health agencies are not doing all they can to make this promising treatment available to Americans suffering from COVID-19. Almost a year ago, Dr. Fauci touted ZYESAMI as a promising treatment for COVID-19.[8] However, the drug remains largely unavailable, and we are told FDA refuses to review the data of NRx’s EUA until the National Institute of Health (NIH) completes clinical trials of ZYESAMI later this year.[9]
Two years into a pandemic and with a death toll exceeding a reported 900,000 Americans, it is unacceptable that the FDA and NIAID are needlessly delaying a treatment for late-stage COVID-19 with a remarkable track record of success. This bureaucratic dragging of your feet appears in stark contrast to the expedited review of other treatments like remdesivir, Molnupiravir, Paxlovid and the COVID-19 vaccines. The FDA’s disparate review processes for different treatments that appears to favor large manufacturers is troubling.
To better understand the FDA’s decisions regarding an EUA for ZYESAMI, we respectfully request the following information:
1. Please provide a timeline of FDA and NIAID actions to review ZYESAMI as an emergency treatment for COVID-19.
2. Please provide documentation of any communications between FDA or NIAID and physicians or hospitals that are utilizing ZYESAMI under Right to Try.
3. Has the FDA ever accepted the data of ongoing clinical trials when issuing an EUA for a treatment for COVID-19? If so, please provide the treatment and its EUA.
4. Please explain why the FDA refuses to review ZYESAMI data until completion of a clinical trial.
5. For COVID patients that received remdesivir and steroids but did not recover, what is the FDA and NIAID’s current treatment recommendation?
https://www.wispolitics.com/2022/u-s-sen-john...HZ8uvMV4Ao
6
