Over the weekend, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for hydroxychloroquine sulfate and chloroquine phosphate drugs, which have been donated by Strategic National Stockpile (SNS), to be made available to those hospitalised with Covid-19. Versions of these drugs have previously been approved by the FDA against malaria.
The Department of Health and Human (HHS) announced simultaneously that Sandoz had donated 30 million doses of hydroxychloroquine sulfate, while Bayer donated one million doses of chloroquine phosphate.
In its letter of authorisation, the FDA stated this decision is because the Secretary of the Department of HHS Alex Azar “declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the Covid-19 outbreak” and that this EUA was to “facilitate the availability of chloroquine phosphate and hydroxychloroquine sulfate during the COVID-19 pandemic to treat patients for whom a clinical trial is not available, or participation is not feasible.”
This EUA is not the same as an FDA approval however. The regulator emphasised in its letter that it “encourages the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of these products in treating Covid-19.”
Other countries have recommended these two products for hospitalised Covid-19 patients based on in-vitro and anecdotal clinical data.