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The FDA decided on a one-day emergency (US) approval to use the Gilead Sciences antiviral remedy as a remedy for children and adult ‘Corona19’ patients hospitalized for serious suspected or confirmed infections. .
Although the efficacy and safety information for use in hospitalized patients due to the ‘Corona 19’ infection is still limited, the FDA believes that in clinical trials, remedyvir reduced the recovery time in some patients. As demonstrated, it was decided to ‘approve emergency use’ on this day.
“As soon as two promising results came out of the National Institutes of Health (NIH) clinical trials, the urgent FDA approval of Remdesibir was a fight against Corona 19,” said the Secretary of the United States Secretary of Health ( HHS) Alex Azar. It was an important step forward and another example that shows that the Trump administration is moving fast to save lives. “
“The NIH, the FDA, and scientists around the world, as well as the United States, have been working tirelessly with patients to ensure these potential ‘corona19’ treatments,” said Azar. of-America) By following the ‘Corona 19’ approach strategy, the government and private industry have been able to cooperate seamlessly and secure treatment options for patients as soon as possible. ”
With approval for urgent use, Remdesibir was launched in the United States, allowing clinicians to use it intravenously for hospitalized patients and children with suspected or confirmed serious crown infections19.
Here, “severe” refers to a case where the patient’s blood oxygen level is low, requires oxygen therapy, or requires more intense respiratory support, such as mechanical oxygen delivery.
“From the beginning, the FDA has been working hard to ensure that the development and use of potential ‘corona19’ therapies can be accelerated,” said Stephen M. Han, FDA general manager. It means that it is an important step forward in our efforts to work closely with patients to ensure that patients have access to new treatment options in a timely manner, while supporting researchers evaluating efficacy and safety. I can give it.
He added: “Since there has been a great deal of interest in finding and equipping ‘therapies to combat’ Corona 19 ‘among all involved, the FDA has been working day and night through the Coronavirus Rapid Development Program (CTAP), as well as the timely treatment. “We have been looking for all available alternatives to help make this happen.”
The FDA conducted evaluations based on ‘approved use’ criteria and assured scientific evidence, and Remdesivir can use them to treat ‘Corona 19’ and it is currently sufficient, licensed or otherwise available. In the absence of a treatment alternative, it was considered reasonable to approve urgent use because the efficacy of this serious or life-threatening virus outweighed the potential risk of using this medicine. It is already decided
With ‘Emergency Use Approval’, Remdesivir also provides important information on medical care and patients with important information when used to treat ‘Corona 19’, including dosage instructions and possible side effects and drug interactions. Must be.
Among the side effects that can occur when using remedyvir are elevated levels of liver enzymes, which can be signs of inflammation or damage to cells within the liver, and hypotension, nausea, vomiting, and sweating. And injection-related reactions, including reactions and tremors.
In this regard, if the current situation declares that the emergency use of unlicensed products is justified, the seriousness or life threatening of unlicensed medical products or medical products that have not yet been approved for such use will be declared. The FDA is deciding “ approval for emergency use ” so that it can be used to diagnose, treat, or prevent a possible disease or symptom.
‘Emergency use in the absence of sufficient, authorized, or other available treatment options for serious or life-threatening diseases or symptoms caused by chemical or biological, radiation, and nuclear threats. It means you can decide ‘approval’.
There is a clear difference between “emergency use approval” and the case where the FDA decides to approve.
The FDA evaluates the evidence obtained in deciding on ’emergency use’ and closely balances the risks that can be expected to be useful when used during emergencies, but that cannot rule out the potential of involving untested products. It is planning.
Before the decision to approve emergency use, the FDA allowed Gilead Sciences to conduct clinical trials and use programs to increase access to individual patients.
The ‘Emergency use approval’ will remain in effect until the end of the situation where it is justified to allow the emergency use of chemical or biological medicines for the prevention and treatment of ‘Corona 19’.
If it is considered that the criteria specified in the law are no longer met, the content of the ‘approval of emergency use’ can be modified or canceled.
