A doc from YMB sent email to Peter Marks, the director of CBER.
“Dr. Marks,
I'm curious about the hold up regarding Leronlimab. It has met the thresholds for an Emergency Use Authorization for use as a treatment for Covid-19. It has been proven, using a multi center double blind, randomized, placebo controlled Phase II study, to be efficacious against SARS-CoV-2 in the the mild to moderate patient population; in a study approved by the FDA. And, Leronlimab has a proven safety profile as demonstrated in studies of over 1,000 patients, for HIV and SARS-CoV-2.
In light of the retrospective and anecdotal evidence used to give Convalescent Plasma an Emergency Use Authorization for use as a treatment in a very narrow subset of early Covid-19 patients, I am left scratching my head as how a multi center double blind, randomized, placebo controlled study of any size could be negated by retrospective and non-blind, non-randomized, and non-use of placebos in uncontrolled studies of even the largest sample sizes (ie. 70,000 patient Mayo study).
I can attest to the fact that myself, and many Physicians and Healthcare Providers are feeling frustrated by what appears to be favoritism played towards large Pharmaceutical Companies who have staff working at the FDA as Consultants. While patients continue to die of inflammation related disorders, due to the out-of-control immune response to the SARS-CoV-2 attack, it seems almost neglectful to offer Remdesivir and supportive measures to such patients. An antiviral vaccine is supposed to be preventative, not used as a therapy for an already induced immune response. And, the use of steroids is contraindicated in patients not requiring oxygen. In addition, comparatively speaking, Leronlimab versus steroids, does not suppress the immune system, but enhances it, reducing viral load to zero, as it reduces inflammation.
So, for mild to moderate patients, Leronlimab is proven to be the most effective against SARS-CoV-2, versus Remdesivir, Steroids and Convalescent Plasma. This patient population is important to treat early for many reasons besides just preventing potential worsening of progression towards serious illness. Our medical community has been overwhelmed by the large influx of SARS-CoV-2 patients, to the detriment of other serving other types of maladies, which include trauma as more people re-enter the workforce. Healthcare Providers need help in getting patients out of the hospitals as quickly as possible. Lest we not forget the cost savings of such measures.
I implore you to ensure that Leronlimab moves quickly through the Emergency Use Authorization process. It needs to be another tool Practitioners can rely on to bring the Pandemic under control!!“
The poster got a generic response.
“Thank you for contacting Dr. Peter Marks. Please accept this response from the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.
Please note that due to confidentiality laws, the FDA cannot divulge information related to applications that may or may not have been submitted to the Agency. All information on an unapproved drug product is confidential and belongs to the sponsor. We understand this can be frustrating when you are just trying to treat the patients.
We encourage you to report, and encourage other physicians to report, your experiences with COVID therapies through CURE ID, an internet-based repository that lets the clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone or other mobile device. More information is available here.
For more information on Emergency Use Authorizations (EUAs), visit:
Emergency Use Authorization
Best Regards,
Holli
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
“Dr. Marks,
I'm curious about the hold up regarding Leronlimab. It has met the thresholds for an Emergency Use Authorization for use as a treatment for Covid-19. It has been proven, using a multi center double blind, randomized, placebo controlled Phase II study, to be efficacious against SARS-CoV-2 in the the mild to moderate patient population; in a study approved by the FDA. And, Leronlimab has a proven safety profile as demonstrated in studies of over 1,000 patients, for HIV and SARS-CoV-2.
In light of the retrospective and anecdotal evidence used to give Convalescent Plasma an Emergency Use Authorization for use as a treatment in a very narrow subset of early Covid-19 patients, I am left scratching my head as how a multi center double blind, randomized, placebo controlled study of any size could be negated by retrospective and non-blind, non-randomized, and non-use of placebos in uncontrolled studies of even the largest sample sizes (ie. 70,000 patient Mayo study).
I can attest to the fact that myself, and many Physicians and Healthcare Providers are feeling frustrated by what appears to be favoritism played towards large Pharmaceutical Companies who have staff working at the FDA as Consultants. While patients continue to die of inflammation related disorders, due to the out-of-control immune response to the SARS-CoV-2 attack, it seems almost neglectful to offer Remdesivir and supportive measures to such patients. An antiviral vaccine is supposed to be preventative, not used as a therapy for an already induced immune response. And, the use of steroids is contraindicated in patients not requiring oxygen. In addition, comparatively speaking, Leronlimab versus steroids, does not suppress the immune system, but enhances it, reducing viral load to zero, as it reduces inflammation.
So, for mild to moderate patients, Leronlimab is proven to be the most effective against SARS-CoV-2, versus Remdesivir, Steroids and Convalescent Plasma. This patient population is important to treat early for many reasons besides just preventing potential worsening of progression towards serious illness. Our medical community has been overwhelmed by the large influx of SARS-CoV-2 patients, to the detriment of other serving other types of maladies, which include trauma as more people re-enter the workforce. Healthcare Providers need help in getting patients out of the hospitals as quickly as possible. Lest we not forget the cost savings of such measures.
I implore you to ensure that Leronlimab moves quickly through the Emergency Use Authorization process. It needs to be another tool Practitioners can rely on to bring the Pandemic under control!!“
The poster got a generic response.
“Thank you for contacting Dr. Peter Marks. Please accept this response from the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.
Please note that due to confidentiality laws, the FDA cannot divulge information related to applications that may or may not have been submitted to the Agency. All information on an unapproved drug product is confidential and belongs to the sponsor. We understand this can be frustrating when you are just trying to treat the patients.
We encourage you to report, and encourage other physicians to report, your experiences with COVID therapies through CURE ID, an internet-based repository that lets the clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone or other mobile device. More information is available here.
For more information on Emergency Use Authorizations (EUAs), visit:
Emergency Use Authorization
Best Regards,
Holli
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
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