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FDA Authorizes Two Drugs for COVID-19

30 March 2020
Giulio Prisco


The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for hydroxychloroquine sulfate and chloroquine phosphate. The EUA permits these drugs to be distributed and prescribed to patients with COVID-19, as detailed in a press release issued by the U.S. Department of Health and Human Services (HHS).

The press release notes that the HHS “accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market.”

CNN emphasizes that, while there's limited evidence on the efficacy of chloroquine or hydroxychloroquine, the FDA said the drugs’ potential benefits outweighed their risk.

As noted in Pulse 144, global attention to chloroquine and hydroxychloroquine was sparked by Chinese researchers who reported treating more than 100 patients with chloroquine, and French researchers who reported treating 20 patients with hydroxychloroquine. The same French researchers have now issued another encouraging report. Similarly encouraging reports keep surfacing.

These are emergency studies done without the strict protocols used in formal clinical trials. But the preliminary results can’t be ignored. And opening potentially life-saving options is more important than following scientific protocols.

What I find very sad is that, in covering the FDA’s emergency authorization, many journalists have chosen to focus on President Trump’s enthusiastic comments on chloroquine and hydroxychloroquine. It seems that, for many journalists, supporting one or another political position is much more important than curing people. I’ll refrain from further comments, which would be very harsh.

Blood Clot Drug Could Help COVID-19 Patients

Researchers at MIT and University of Colorado have proposed a temporary measure that could possibly help COVID-19 patients who are in acute respiratory distress. The researchers are persuaded that a drug, that is now used to treat blood clots, could help people in cases where a ventilator is not helping, or if a ventilator is not available.

A study published in Journal of Trauma and Acute Care Surgery suggests that some COVID-19 patients have a profound disorder of blood clotting that is contributing to their respiratory failure. And a protein, called tissue plasminogen activator (tPA), which is commonly given to heart attack and stroke victims, could help.

Some CV Drugs May Increase COVID-19 Risk

Scientists at Louisiana State University have proposed a possible explanation for the severe lung complications being seen in some people diagnosed with COVID-19.

A study published in Journal of Travel Medicine suggests that patients treated with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) may be at increased risk of severe disease outcomes due to COVID-19 infections. ACEIs and ARBs are highly recommended medications for patients with cardiovascular diseases including heart attacks, high blood pressure, diabetes, and chronic kidney disease.

Supercomputer Models Coronavirus for New Drugs

Scientists at Texas Advanced Computing Center (TACC) are developing a supercomputer model of the coronavirus. They expect the model will give insight into how the virus infects in the body.

A research paper published in ACS Central Science describes how the scientists have tested the first parts of the model and optimized code on the Frontera supercomputer at TACC.

The scientists are persuaded that the knowledge gained from the full model will help researchers design new drugs and vaccines to combat the coronavirus.

Most Comprehensive Human Cell Model to Date

Researchers at University of Illinois have developed the first computational model of a human cell and simulated its behavior for 15 minutes. This is the longest time achieved for a biological system of this complexity.

The simulation is described in a paper published in PLOS Computational Biology. It sheds new light on some of the genetic processes that control the regulation and development of human traits and some human diseases.

The researchers noted that their open access computational model is the most comprehensive human cell model to date. And it has ample room for endless advancement and customization.

Young Immune Cells Boost Cancer Immunotherapy

Scientists at Washington University have suggested that the age of certain immune cells used in cancer immunotherapy plays a role in how effective it is.

A research paper published in Developmental Cell indicates that natural killer (NK) immune cells appear to be more effective the earlier they are in development.

This opens the door to the possibility of an immunotherapy that would not utilize cells from the patient or a matched donor. Instead, effective immune cells could be developed from existing supplies of human pluripotent stem cells.

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