FDA testing coronavirus treatments including chloroquine, plasma from recovered COVID-19 patients

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Around the World Front Page Just in US approves chloroquine as treatment for COV-19 By Chike Olisah

President Donald Trump says the US Food and Drug Administration has approved chloroquine, a drug used to treat malaria and severe arthritis, for coronavirus treatment.

"And we're going to be able to make that drug available nearly immediately", Trump said.

"They've gone through the approval process - it's been approved". He said trials are necessary to determine if they provide effective treatment against the coronavirus and in what dosage.

"It's been around for a long time, so we know if things don't go as planned, it's not going to kill anybody", he said today.

The FDA plans to study the results of those drugs in hopes that they can be offered as "bridge" therapies as they await completion of clinical trials for a vaccine, which may take a year, FDA Commissioner Dr. Stephen Hahn said. Technically, doctors can already prescribe the drug to patients with COVID-19, a practice known as off-label prescribing.

"Our industry has invested billions in existing therapies that can potentially be used to treat infected patients", said PhRMA President and CEO Stephen J. Ubl.

During an at-times-confusing White House press conference, Trump said that chloroquine was approved for use and that he wanted to "remove every barrier" to test more drugs against Covid-19 and "allow many more Americans to access drugs that have shown really good promise". But he cautioned that there is limited availability of the drug, and many patients with rheumatoid arthritis rely on it.

Trump said the measures he announced on Thursday could be a "game-changer", but "maybe not".

That drug has only been approved for a clinical trial, not for consumer use. "The only thing we weren't prepared for was the media".

Packets of Nivaquine tablets containing chloroquine, and Plaqueril tablets containing hydroxychloroquine, drugs that have shown signs of effectiveness against the CCP virus, at the IHU Mediterranee Infection Institute in Marseille, France, on February 26, 2020.

The president made brief remarks, then left the podium to Pence, Fauci, Redfield and others in the White House's task force.

That may mean prescriptions of the drug will only be approved for use in the most severely ill patients, although Hahn did not specify the criteria for prescribing hydroxoychloroquine to coronavirus patients. Another option might be to take blood from patients who've recovered from a coronavirus infection and inject it into sick patients to help their immune response.

"It (chloroquine) has been around for a long time and it's very powerful..."

The agency's standard for drugs is to look at the risk posed by side effects compared with how effective treatments are.

The study is part of the initiative from an independent group of scientists and physicians working on an open-data clinical trial for prevention of COVID-19, through the use of hydroxychloroquine in combination with other therapeutic agents.

Dr Andrew Preston, of the University of Bath, said: 'Among the oppressive darkness of the current situation, any glimmer of hope is very welcome'. Running in the thousands of dollars per unit, ventilators are used to help people with respiratory difficulties to breathe. However, clinical use should either adhere to the Monitored Emergency Use of Unregistered Interventions (MEURI) framework or be ethically approved as a trial as stated by the World Health Organization. "Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes", Fauci said in a statement from the NIH.

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