Ebola drug Remdesivir is used to treat COVID-19

Emerging as a new COVID-19 treatment

Clinical trials have already begun & budget, time savings

Remdesivir by Gilead, which is being developed as an Ebola treatment, is expected to benefit significantly from the spread of COVID-19.

 

The explosive demand for therapeutics around the world has led to unintended recruitment of clinical trials, which has resulted in significant time and cost savings.

 

In some cases, the possibility of quick permits is also increasing.

 

Clinical trials in the US, China, etc, Skip Prior Authorization The National Institute of Allergy and Infectious Diseases (NIAID) announced on the 12th that it will begin a clinical trial of Remdesivir with COVID-19.

 

Remdesivir is a drug that Gilead Science is developing for the Ebola virus, and it is preparing for phase III full-scale after completing phase II clinical trials, However, the analysis predominates that the recruitment of the Ebola virus patient population will be limited and it will take some time due to the budget and time constraints for multinational clinical trials.

 

It is a fact that some aspects of the permit has been placed in a somewhat opaque situation.

 

However, with the rapid rise of Remdesivir in the treatment of new COVID-19, the demand has risen sharply and the environment is ready for immediate clinical trials without prior review and approval.

 

This has been decisive in the case of the first COVID-19 patient from the United States.

 

Indeed, researchers in the Centers for Disease Control and Prevention (CDC) have received a lot of attention from the New England Journal of Medicine (NEJM), with a case report describing the first patient prescribed Remdesivir.

 

At the time, the patient was given other antiviral agents and antibiotics, but the symptoms got worse.

 

Eventually, the administration of Remdesivir improved significantly.

 

Since the Ebola virus is an RNA virus such as COVID-19, Remdesivir, which has a mechanism that prevents RNA replication, also inhibits COVID-19.

 

NEJM Case Report Critical Leads to a quick permit As these effects become known, patients in China and Thailand are already taking Remdesivir in patients.

 

The Chinese government has also urged Gilead to cooperate urgently and to expand the supply of Remdesivir.

 

The same is true for large-scale clinical trials in China ahead of the United States.

 

As soon as the potential for treatment was recognized, the Chinese health authorities immediately approved the medication in the form of clinical trials without prior review or approval.

 

As a result, China has already entered into a controlled trial of 761 patients and is planning to proceed with the trial until April, and then review the rapid approval.

 

This is not the only case in China.

 

The U.S.

 

Food and Drug Administration (FDA) and the CDC also mention rapid approval.

 

Since the drug is already in the form of phase III clinical trials, it is in a position to grant a new drug based on this result.

 

This fact has already been communicated to foreign countries through the New York Times and international press, and for this reason, China and Thailand are reportedly preparing for clinical trials and rapid approval.

 

At the end of last year, the drug, which had even entered phase III clinical trials, was opaque, and in a few months, the phase III clinical trial could be approved for rapid approval.

 

For Gilead, this is a great opportunity to save a great deal of time and budget in collecting patients, selecting institutions, and systematically analyzing them to prepare for permits.

 

However, it is confirmed that clinical trials and rapid approvals are not being reviewed in Korea yet.

 

As China's demand is so large that it attracts the world's quantity, it is not easy to consider prescription even in Korea.

 

"Remdesivir is expected to be effective, but it is not easy to even prescribe it due to the lack of stock in our country, and for this reason, the policy recommendation was to exclude from primary treatment", said Jihwan Bang, the team leader of the central clinical task force (TF).

 

An official from the Ministry of Food and Drug Safety said, "No immediate approval has been reviewed regarding COVID-19 treatment".