La Food and Drug Américaine (FDA) et le département américain de la santé (HHS) ont autorisé en urgence la prescription de l’hydroxychloroquine contre le COVID19 car même si les preuves scientifiques de son efficacité sont légères, son bénéfice potentiel excède les risques potentiels connus
HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients
FDA issues emergency use authorization for donated hydroxychloroquine sulfate, chloroquine phosphate
The U.S. Department of Health and Human Services (HHS) today 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 hospitalized 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.
“President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope,” said HHS Secretary Alex Azar. “Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine. The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”
HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) worked with colleagues within HHS, the companies, the Department of State, and the Department of Homeland Security to secure the donated shipments. Given the importance of understanding the efficacy of these medications for the treatment and prevention of COVID-19, federal agencies, such as the National Institutes of Health and ASPR’s Biomedical Advanced Research and Development Authority (BARDA), are working together to plan clinical trials.
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions.
The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states. The SNS does not regularly stock either drug.
Hydroxychloroquine sulfate and chloroquine phosphate are oral prescription drugs approved to treat malaria and other diseases. Although there are no currently approved treatments for COVID-19, both drugs have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.
When the Secretary of Health and Human Services declares that issuance of an EUA is appropriate, the FDA has the regulatory emergency use authority to facilitate access to unapproved medical countermeasures or unapproved uses of approved medical countermeasures needed to prepare for and respond to chemical, biological, radiological and nuclear threats.
An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives. Emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application.