A potential new therapeutic drug that tackles those infected with the Wuhan coronavirus has yielded excellent results. Gilead Sciences Inc.’s drug remdesivir appears to be an effective antiviral. Dr. Anthony Fauci, one of President Trump’s top officials on the Wuhan coronavirus task force, was impressed with the study. And now the Food and Drug Administration has given it emergency authorization use. The full results are expected sometime in May, but the company noted the drug has achieved its main goals (via Reuters):
Dr. Fauci on the clinical trial for potential coronavirus treatment drug remdesivir:
— NBC News (@NBCNews) April 29, 2020
“[The study data] shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recovery;” says remdesivir improved recovery time from 15 days to 11 days. pic.twitter.com/1WNCO3c5hI
Breaking News: The FDA plans to authorize emergency use of the experimental antiviral drug remdesivir for coronavirus treatment. Dr. Anthony Fauci expressed cautious optimism about early trial results.https://t.co/ERJySqWQIm pic.twitter.com/fQEcNNyjhp
— The New York Times (@nytimes) April 29, 2020
Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as “highly significant.”
“This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.”
[…]
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug under five-day and 10-day regimens.
In that 397-patient trial, Gilead said clinical improvements were similar regardlesss of treatment duration, and patients treated early on with remdesivir did better than patients who were treated later in the course of infection.
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host’s immune system.
The company is also studying the drug in patients with less severe COVID-19, but those results are not expected until later next month.
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Now, with the government's seal of approval, Gilead says it could have over 140,000 treatments available by the end of the month (via WSJ):
Gilead is talking with other drug-makers to help organize supply chains that can help get remdesivir to patients globally, Chief Financial Officer Andrew Dickinson said on a conference call with analysts to discuss first-quarter earnings.
He cautioned, though, that some of the substances used to make remdesivir are scarce, and the company wants to be careful not to disrupt its own supply chain, which is the quickest route to get the drug to patients.
“Our primary focus is on providing access to patients around the world,” said Mr. Dickinson.
The company said it expects “more than one million treatment courses will be manufactured by December 2020, with plans to be able to produce several million treatment courses in 2021.”
Gilead will donate the more than 140,000 treatment courses it expects to manufacture by the end of May, but has indicated that it will charge money for the drug after that time.
Chief Executive Daniel O’Day said again on Thursday that the company will be thoughtful about creating a sustainable business model for the drug going forward that makes it affordable and accessible to patients globally.
With no vaccine against the coronavirus yet, this could be a good stopgap in the case of a second wave of infections. President Trump said in a town hall last night at the Lincoln Memorial that he expects to have a vaccine by the end of the year.
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