Patients suffering from 2019 coronavirus disease (COVID-19) in the United States can now be officially treated with hydroxychloroquine as the Food and Drug Administration (FDA) has sanctioned the treatment.
The FDA granted emergency authorisation for hydroxychloroquine, a known anti-malaria drug, to be used for the treatment of COVID-19 on Sunday.
The Department of Health and Human Services disclosed this in a statement.
Previously the drug’s prescription to treat the virus was considered “off-label” use.
The use of the drug — often paired with azithromycin — has not yet been proven in clinical trials to be effective against the disease. However, given reported success in a growing number of small, non-randomised studies; as well as testimonials from doctors and patients about the use of the “off-label” drug regimen, doctors are said to be prescribing the treatment to patients who are severely ill. Anecdotally, many doctors are taking it prophylactically.
But with the emergency authorisation, hospitals and doctors are permitted to formally prescribe hydroxychloroquine and chloroquine to treat coronavirus patients.
“The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorisation (EUA) to BARDA (Biomedical Advanced Research and Development Authority) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalised teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” HHS’s statement read in part.
HHS added, it “accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalised with COVID-19 or for use in clinical trials.
“These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market.“
Addressing concerns the EUA could lead to shortages of the drug, HHS stated that “use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.”