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U.S. Allows Emergency Use of Drug Trump Backed Against Virus (3)

March 30, 2020, 5:13 PM

A drug President Donald Trump backed as a possible “game changer” in the fight against the coronavirus pandemic received an emergency-use designation from U.S. regulators, even as signs of risk continued to mount.

The Health and Human Services Department accepted 30 million doses of the drug, hydroxychloroquine, from Novartis AG’s Sandoz unit, Secretary Alex Azar said in a statement late Sunday.

Normally used to treat malaria, hydroxychloroquine yielded promising yet inconclusive results in a small coronavirus trial. While Trump has said the drug is safe, it does carry significant side effects. Some people have been sickened, with reported deaths in the U.S. and France, after taking various versions to try to ward off the new illness.

Trump said 1,100 patients in New York City are getting treatment using hydroxychloroquine. As global cases surged past 700,000, the city has emerged as one of the pandemic’s hot spots.

“Let’s see how it works,” Trump said in his daily briefing Sunday. “It may, it may not.”

WATCH: President Donald Trump and the head of the Food and Drug Administration, Stephen Hahn, gave apparently conflicting comments about the availability of chloroquine, a malaria drug, to treat Covid-19 patients.
Markets: European Open.” (Source: Bloomberg)

Some Covid-19 patients treated at French hospitals with hydroxychloroquine and chloroquine, another malaria drug, experienced fatal heart side effects, Le Point reported. Australian health officials have restricted the use of the two drugs for treatment of Covid-19, the illness caused by coronavirus.

‘No Shortcuts’

WHO Director-General Tedros Adhanom Ghebreyesus has also cautioned against the use of unproven treatments against coronavirus.

“The history of medicine is strewn with examples of drugs that worked on paper or in a test tube but didn’t work in humans or were actually harmful,” he said last week in a briefing. “We must follow the evidence. There are no shortcuts.”

A rush to use medicines against coronavirus could also cause shortages for patients with illnesses that the drugs are normally used to treat. India banned exports of hydroxychloroquine to maintain supplies needed to combat malaria.

The Food and Drug Administration gave emergency use authorization to hydroxychloroquine and chloroquine, according to the statement. The agency can authorize emergency use when there are no available alternatives and the “known and potential” benefits of the product outweigh the risks.

The West African countries of Nigeria and Burkina Faso will begin clinical trials of chloroquine for emergency treatment of the virus. A local drugmaker, May & Baker Plc, has been asked to produce a batch of chloroquine, and more may be manufactured if cases in the country spike, Nigerian drug regulators said Monday.

Burkina Faso has approved trials of both chloroquine and the antibiotic azithromycin, which will start April 6 and take eight weeks. Provisional results will be released within two weeks, authorities said.

Italian Trials

Italian regulators have also cleared the antimalarial drugs, along with a group of antivirals used to treat HIV, for testing against Covid-19, the Chinese Xinhua news agency reported on Friday. Italy has reported more than 10,000 deaths from the disease, the most in the world.

How chloroquine and hydroxychloroquine might fight viruses remains unknown. Researchers have theorized that they may block entry to or replication within cells.

Efforts to find solutions to the coronavirus’s advance are mounting as the number of worldwide cases soars, and health systems in Italy and Spain threaten to crack under the burden of desperately ill and contagious patients. A variety of treatments, including Gilead Sciences Inc.’s remdesivir, are currently in randomized, controlled clinical trials.

Scientists are also investigating the utility of a tuberculosis vaccine that’s been used for about a century to see whether it will bolster the body’s immune system against coronavirus. Called BCG, or Bacillus Calmette-Guerin, the shot is being given to health-care workers in Melbourne to see whether it will protect them.

(Updates with theories of how drug works in third paragraph from bottom.)

--With assistance from Jason Gale, Thomas Mulier, Pauline Bax, Simon Gongo, Anthony Osae-Brown and Marthe Fourcade.

To contact the reporter on this story:
John Lauerman in London at jlauerman@bloomberg.net

To contact the editors responsible for this story:
Eric Pfanner at epfanner1@bloomberg.net

Anne Pollak

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

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