FDA to Issue Emergency Use Authorization for Antiviral Drug After Trials Show Its Effectiveness Against Coronavirus

|
|
Posted: Apr 29, 2020 2:10 PM
FDA to Issue Emergency Use Authorization for Antiviral Drug After Trials Show Its Effectiveness Against Coronavirus

Source: AP Photo/Gerald Herbert

UPDATE: NYT is reporting that the FDA is planning to issue emergency use authorization for this drug:

The F.D.A. plans to announce as early as Wednesday an emergency use authorization for remdesivir, an experimental antiviral drug that is being tested in treating patients with Covid-19, the disease caused by the coronavirus, according to a senior administration official.

Ahead of the announcement President Trump and Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, on Wednesday hailed early trial results of the drug, holding out hope that it could help stem the rising death toll.

Meeting with reporters at the White House, Dr. Fauci cautioned that the results of the study overseen by his agency, the National Institute of Allergy and Infectious Disease, still need to be properly peer reviewed but expressed optimism that it could make a difference in speeding up the recovery of some patients infected with the virus.

[...]

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead. 

A representative for Gilead said in an email Wednesday that “as we have done since the beginning of the pandemic, we have been sharing information, transparently and as it becomes available, with the administration, other officials and the public.”

***Original Post***

The fight against the Wuhan coronavirus is an effort on multiple fronts. American industry has been mobilized to make ventilators, medical masks, medical gowns, and hand sanitizer. My Pillow, Brooks Brothers, distilleries, and General Motors are just some of the many companies that have retooled their production capacities to provide those on the frontlines with the equipment that they need. Our testing capacity is ramping up, with the Trump administration saying enough resources will be available to all states as the nation moves towards slowly re-opening. We still don’t have a vaccine, but that’s an ongoing process. Antibody tests are also being conducted, but we could have a successful therapeutic on the horizon. 

Gilead Sciences has been testing an antiviral treatment, remdesivir, for COVID patients and the results have been excellent. It caused the markets to surge mid-April when it was reported that most of the patients who took remdesivir were discharged. The University of Chicago Medicine selected 125 people for this test. Now, Gilead says that the report on their trials is due out in mid-May, with preliminary results possibly being released earlier than that, but the company said that concerning improving the health of patients infected with coronavirus, remdesivir proved to be a successful treatment (via Reuters):

Gilead Sciences Inc on Wednesday said its experimental antiviral drug remdesivir helped improve outcomes for patients with COVID-19, and provided data suggesting it worked better when given earlier in the course of infection.

[…]

Results from that trial have been highly anticipated because it compares how patients who received remdesivir fared versus patients who did not. The lead researcher on that trial told Reuters on Friday that results could come by mid-May, with preliminary findings possible even earlier.

More detailed information on that study will be provided at a later date, Gilead said.

Gilead also provided data on a study that it has conducted in dozens of medical centers, which does not compare the use of remdesivir against a placebo.

In that trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated late.

And as Cortney wrote, this drug has caught the eye of the Trump administration, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and a key player in Trump’s Wuhan coronavirus task force. 

Editor's Note: Want to support Townhall so we can keep telling the truth about China and the virus they unleashed on the world? Join Townhall VIP and use the promo code WUHAN to get 25% off VIP membership!