Despite what President Donald Trump said at a White House briefing on Thursday, the Food and Drug Administration (FDA) hasn't approved chloroquine and its less-potent-but-safer offspring, hydrochloroquine, to treat COVID-19, the disease caused by the new coronavirus.
"Normally the FDA would take a long time to approve something like that, and it's -- it was approved very, very quickly and it's now approved, by prescription," Trump said.
Neither chloroquine nor hydrochloroquine are approved by the FDA to treat COVID-19, but they are approved to treat malaria -- and have been for decades. Hydrochloroquine is also used to treat lupus and rheumatoid arthritis since it has anti-inflammatory properties.
For most medications, the FDA gives doctors leeway to prescribe drugs for whatever disease they think the drug will help. So-called off-label prescriptions can allow sales to ramp up between when new clinical trial results are presented at medical meetings and when the FDA finally approves the expanded indication months later.
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Unfortunately, there's minimal evidence to suggest that the two drugs help patients with COVID-19. Scientists in China have shown the drugs can inhibit growth of the coronavirus that causes COVID-19 in cells grown in a laboratory.
Doctors in France have reportedly tested hydroxychloroquine on 24 patients. It showed that patients treated with the drug plus the antibiotic azithromycin reduced the amount of virus in the patients, but larger studies with control groups will be required to know for sure if chloroquine or hydrochloroquine actually helps patients.
"We want to do that in the setting of a clinical trial -- a large, pragmatic clinical trial -- to actually gather that information and answer the question that needs to be answered and -- asked and answered," FDA commissioner Stephen Hahn said at the conference.
Multiple drugmakers, including Bayer (OTC: BAYRY), Teva Pharmaceutical (NYSE: TEVA), and Novartis (NYSE: NVS) have committed to donating chloroquine or hydrochloroquine tablets. And Mylan (NASDAQ: MYL) and Amneal Pharmaceuticals (NYSE: AMRX) plan to ramp up production of hydroxychloroquine.
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