Antimalarials Not Formally Approved, But Access Is Being Expanded – FDA

The Food and Drug Administration says though antimalarials have not been formally approved as cure for the Coronavirus, still the agency is expanding access so that authorities could gather more data.

President Trump had on Thursday said that the US is fast-tracking antimalarial drugs for use as a treatment against the new coronavirus.

FDA Commissioner Stephen Hahn speaking on the matter said the access being granted falls under what is called “compassionate use.”

Mr Hahn notes that, “If there is an experimental drug that is potentially available, a doctor could ask for that drug to be used in a patient. We have criteria for that and very speedy approval for that.

“As an example, many Americans have read studies and heard media reports about this drug chloroquine, which is an anti-malarial drug.

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“It’s already approved, as the president said, for the treatment of malaria as well as an arthritis condition.

“That’s a drug that the president directed us to take a closer look at, as to whether an expanded use approach to that could be done to actually see if that benefits patients.”

The announcement follows encouraging research into chloroquine and hydroxychloroquine in France and China, but many in the wider scientific community have cautioned more work is needed to prove they really work for COVID-19.

Chloroquine is a synthetic form of quinine, which has been used to treat malaria since the 1940s. Hydroxychloroquine shares a similar mechanism of action but is less toxic.

French drug maker Sanofi on Wednesday said it stood ready to offer the French government millions of doses of hydroxychloroquine, sold under its brand name Plaquenil, in light of a “promising” study carried out by Didier Raoult of the IHU Mediterranee Infection in Marseille.

Raoult reported this week that after treating 24 patients for six days with Plaquenil, the virus had disappeared in all but a quarter of them. The research has not yet been peer reviewed and published.