EMA refuses to approve chloroquine for COVID-19 without sufficient data

pharmafile | April 3, 2020 | News story | Medical Communications COVID-19, chloroquine, coronavirus 

The European Medicines Agency has restricted the general use of the drug chloroquine for coronavirus, but allowing its testing in clinical trials.

The drug has already been approved to treat malaria and autoimmune disease and these patients can still receive the treatment. However, people with COVID-19 must be on a trial to get the drug.

This is in contrast to the United States, with the FDA issuing an emergency authorization for chloroquine saying that research suggests it may have some benefits to people suffering from coronavirus.

The data supporting chloroquine’s supposedly effective treatment has come under scrutiny. Some of it comes from Professor Didier Raoult and his study of 36 people in France. Raoult said he cured 100% of the patients but left out that six dropped out after the first six days and they either either died, were transferred to the ICU or couldn’t tolerate the drug.

But a study out of Wuhan is getting more positive attention, where researchers tested the drug in 62 people with mild to moderate COVID-19 in a controlled studied. The group received standard care, with half the group also being tested with hydroxychloroquine. In patients who received the drug the time to clinical recovery was significantly shorter.

The authors of the study wrote: “Considering that there is no better option at present, it is a promising practice to apply HCQ to COVID-19 under reasonable management. However, large-scale clinical and basic research is still needed to clarify its specific mechanism and to continuously optimize the treatment plan.” 

In the US, the FDA has allowed this drug to be donated to the Strategic National Stockpile. Novartis’s Sandoz has donated 30 million doses to the stockpile while Bayer has donated 1 million doses of chloroquine.

Conor Kavanagh

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