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FDA Approves Emergency Use of Promising Drug

 

Last updated 5/13/2020 at 10:35am



It is not the miracle drug many are hoping for to be able to prevent the coronavirus, or treat it on-hand, but it’s a start to help speed up the recovery for those who contract it.

The emergency use of an experimental drug appearing to help patients recover faster was approved, announced in a statement by President Donald Trump, who was alongside Gilead CEO Daniel O’Day and Food and Drug Administration Stephen Hahn.

“This was lighting speed in terms of getting something approved,” Hahn said, adding that this drug is an “important clinical advance.”

The nation’s top infectious disease expert and the director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci gave praise to the drug, adding that it would become a new standard of care for severely ill patients. It has not been tested on those with milder illness.

The FDA acted after preliminary results from a NIH study showed that 1,063 patients tested with remdesivir took 11 days to recover versus 15 days for others.

The emergency use order allows the drug to be distributed to health care providers and administered to hospitalized patients of the virus.

Trump added that the U.S. government is putting its full power and might behind the promising drug for treatment, even saying, “We think we are going to have a vaccine by the end of this year.” But public health officials say a vaccine is a year to 18 months away.

However, like with many drugs, there are side effects. With remdesivir, side effects include potential inflammation of the liver, as well as problems related to its infusion, leading to nausea, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, according to the FDA.

There are currently no drugs approved as of right now to treat the virus, as remdesivir will still need formal approval.

The FDA later approved Moderna’s coronavirus vaccine candidate that started human trials in March for Phase II. This means that a company can expand its clinical study and the vaccine will be given to more people, according to the Centers for Disease Control and Prevention. The company is about one of 100 research groups around the world searching for vaccines to fight against the virus. Dr. Fauci noted that this vaccine candidate shows “impressive” results.

The vaccine uses messenger RNA, or snippets of a virus’s genetic material, rather than a version of the virus itself.

Although no type of mRNA vaccine has been approved for use in humans, Fauci pointed out that animal trials show that small doses of the virus’s mRNA have generated a strong immune response.

On May 9, FDA also announced the emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The atigen test is the third type of test to be authorized by the FDA, which can rapidly detect fragment of virus proteins in samples collected from swabs swiped inside the nasal cavity, FDA said in a statement.

The FDA previously allowed the emergency use of hydroxycholorquine, a malaria drug, for patients hospitalized unable to take part in ongoing studies of the medication. Trump repeatedly promoted it as a possible treatment, however, no large high-quality studies have shown the drug works for that, and it has significant safety concerns.

 
 

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