We’ve been talking about anti-malaria drug hydroxychloroquine for about three weeks now. However, U.S. health agencies like FDA and CDA, are still very cautious about the effectiveness and safety of the two drugs due to small trial size and lack of sufficient data.
In France, the government caved to pressure from renowned Dr. Didier Raoult, who led the new additional study on 80 patients, results show a combination of Hydroxychloroquine and Azithromycin to be effective in treating COVID-19. Dr Didier Raoult, a professor of infectious diseases who works at La Timone hospital in Marseille, then declared in a video on YouTube that chloroquine was a cure for Covid-19 and should be used immediately.
Dr. Raoult reportedly walked out of the scientific advisory committee advising the government after allegations that the government was being influenced by the big pharmaceutical companies which wanted to block hydroxychloroquine because it was cheap, being out of patent.
In another report, France now allows drug chloroquine to be given to coronavirus patients with extreme case of the disease. Health Minister Olivier Veran said on Monday, “The anti-malarial drug chloroquine can be administered in France to patients suffering from the severest forms of the coronavirus but only under strict supervision.” Veran also cautioned: “The high council recommends not to use this treatment… with the exception of grave cases, hospitalized, on the basis of a decision taken by doctors and under strict surveillance.”
Italian government also announced on Friday that hydroxychloroquine and chloroquine could be used to treat all coronavirus patients. Italian government also said the payment will be paid for entirely by the Italian national healthcare system. Yesterday, we also reported that Hungary, the United Kingdom and India, have all banned export of the anti-malarial drugs to explore the usage in treating coronavirus patients in their respective countries.
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……….