FDA authorises donated hydroxychloroquine, chloroquine for emergency use amid COVID-19 outbreak

The US Department of Health and Human Services (HHS) said the FDA has issued an emergency-use authorisation to the Biomedical Advanced Research and Development Authority (BARDA) to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be used to treat hospitalised adults and adolescents with COVID-19, when a clinical trial is not available or feasible. The decision comes as the HHS accepted 30 million doses of hydroxychloroquine donated by Novartis and 1 million doses of chloroquine donated by Bayer for possible use in treating patients hospitalised with COVID-19 or for use in clinical trials.

Earlier this month, Novartis and Bayer, as well as Teva, announced their intention to donate the antimalarial drugs as part of international efforts exploring use of the medicines to treat patients with COVID-19 infection. Bayer said at the time that it would provide 3 million tablets of Resochin (chloroquine phosphate), while Novartis indicated that it would donate up to 130 million doses of hydroxychloroquine by the end of May.

Carol Lynch, president of Novartis' Sandoz unit, said "with this donation to HHS, we are helping to scientifically answer the question of whether hydroxychloroquine may play a role in treating COVID-19." US President Donald Trump recently touted use of hydroxychloroquine, taken together with antibiotic azithromycin, as potentially "one of the biggest game-changers in the history of medicine" and urged them to be deployed. However, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, has cautioned that much of what is known about the drug is based on "anecdotal reports."

The HHS stated that while there are no currently approved treatments for COVID-19, both hydroxychloroquine and chloroquine "have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2." It noted that "anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalised COVID-19 patients, [but] clinical trials are needed to provide scientific evidence that these treatments are effective." Meanwhile, the Strategic National Stockpile, which does not regularly stock either drug, will work with the Federal Emergency Management Agency to ship donated doses to states, the HHS added.

Last month, officials in China suggested that chloroquine be included in the next version of the country's COVID-19 treatment guidelines as it "has a certain curative effect" on the coronavirus.

For related analysis, see ViewPoints: Hydroxychloroquine COVID-19 data will test the balance between speed and rigor.

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