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FDA issues emergency-use authorization for anti-malaria drugs amid coronavirus outbreak


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The Food and Drug Administration (FDA) on Sunday issued an emergency-use authorization for a pair of anti-malaria drugs as health officials work to combat the rapid spread of the novel coronavirus.

 

The Department of Health and Human Services (HHS) said in a statement that the authorization would allow 30 million doses of hydroxychloroquine sulfate and 1 million doses of chloroquine phosphate to be donated to the Strategic National Stockpile. The doses of hydroxychloroquine sulfate were donated by Sandoz, while the chloroquine phosphate was developed by Bayer Pharmaceuticals. 

 

The products will 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," HHS said. 

 

President Trump has repeatedly touted the anti-malaria drugs as a possible coronavirus "game changer," despite warnings from health officials that not enough is known about their effects on COVID-19. Dr. Anthony Fauci, the government’s top infectious disease expert, said during a press briefing earlier this month that much of what is known about the drug is based on "anecdotal reports."

 

"It was not done in a controlled clinical trial, so you really can’t make any definitive statement about it," he said. 

 

Hydroxychloroquine sulfate and chloroquine phosphate are oral prescription drugs typically used to treat malaria and other diseases, HHS noted. The department acknowledged that there are no approved treatments for COVID-19 but said that "both drugs have shown activity in laboratory studies against coronaviruses."

 

The department said that clinical trials are still needed to "provide scientific evidence that these treatments are effective." 

 

"Scientists in America and around the world have identified multiple potential therapeutics for #COVID19, including chloroquine and hydroxychloroquine," HHS Secretary Alex

 

Azar said in a tweet following the announcement. "Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope."

The FDA has permitted New York state to test the anti-malaria drugs on certain patients, Politico reported.

 

The coronavirus, which first appeared in China in December, has infected more than 732,000 people worldwide, including roughly 143,000 individuals in the U.S., according to a Johns Hopkins University database.

 

The outbreak has led to sweeping social distancing measures designed to slow the spread of the disease and lessen the strain on health care systems experiencing a surge in patients. Trump announced on Sunday that many of the federal guidelines in the U.S. would remain in place through April 30.

 

sauce

 

Russia presents Covid-19 TREATMENT based on existing anti-malaria drug

 

Russian specialists said they've come up with an effective way to treat Covid-19 using an anti-malarial drug. This type of medication is now widely researched around the globe as a possible remedy from the pandemic.

 

While experts around the world have been trying to create a specific vaccine against the virus behind the global outbreak, there have also been active attempts to re-purpose existing medicines to help the scores of patients that badly need treatment.

 

After anti-malarial drugs were used in China, which managed to curb the coronavirus outbreak on its soil, they became the subject of research in many countries, including the US, Canada, France and others.

 

US President, Donald Trump, has been actively promoting hydroxychloroquine and chloroquine as "biggest game-changers" in the fight against the highly contagious disease, which already killed more than 1,900 in America and almost 30,000 worldwide.

 

The Russian pharmacists also believe in the effectiveness of malaria medication against the virus, but suggested that another drug — Mefloquine — should be employed. They said their treatment was developed taking Chinese and French experience into account.

 

The drug, which has been around since the 1970s, blocks the degenerative effect Covid-19 has on cells and doesn’t allow the virus to replicate further, the Russian Federal Medical-Biological Agency (FMBA) said in a statement. They added that Mefloquine’s immuno-suppressive effect prevents the inflammatory response caused by the disease.

 

The Russian medics have been working on “an effective and safe scheme to prevent coronavirus infection on the basis of mefloquine, which not only would overcome the peak of incidence but would also effectively control it in the future,” the FMBA said.

 

There have been 228 new coronavirus cases registered in Russia in the last 24 hours, bringing the overall number of infected to 1,264. Up to seven people, who had tested positive for Covid-19, have died.

 

sauce

 

 fingers crossed

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