MFDS is considering changing the permission of Remdesivir

It was discussed at the Central Pharmaceutical Affairs Council on the 7th

Will the controversy over the efficacy end?

Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved.

 

In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results.

 

At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market.

 

According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change.

 

On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held.

 

For now, there is a high possibility of Veklury's permission to change.

 

The U.S.

 

FDA officially approved Remdesivir in October last year.

 

In a clinical trial conducted on 1,062 COVID-19 patients in the United States, the Remdesivir-treated group showed 10 days to recover, and the placebo-treated group showed 15 days, indicating that it was effective in shortening treatment time.

 

However, the WHO announced that Remdesivir was not effective, sparking controversy.

 

In October last year, the WHO reported that in a large-scale clinical trial, Remdesivir was found to have little or no effect in overall mortality, hospitalization period, and need for ventilation.

 

In a small clinical trial released in July this year, Remdesivir drew attention by saying that it had no antiviral effect.

 

In Korea, researchers at 20 university hospitals led by Professor Baek Kyung-ran of Infectious Diseases at Samsung Medical Center earlier this year announced the results of clinical effects.

 

As a result of the analysis of 110 patients, 22.9% of the Remdesivir dosing group deteriorated enough to apply mechanical respiration as of the 28th day of hospitalization, lower than that of other treatment groups (44.7%).

 

Based on this, some argued that Remdesivir should be administered early to severely ill COVID-19 patients.

 

In Korea, Remdesivir and Dexamethasone, which controls immune response inflammation, are used in combination for severely ill patients who are hospitalized and treated.

 

According to Central Disease Control Headquaters, Veklury was administered to 172 hospitals and 22,571 patients by the 3rd.

 

Currently, only Remdesivir and Celltrion's Regkirona are approved treatments for COVID-19.

 

Regkirona is being used to treat mildly high-risk COVID-19 and all secondary adult patients with permission to change.

 

Currently, the MFDS is reviewing the EUA, Merck's oral treatment, and Pfizer's products are also being reviewed in advance before the approval review.

 

Remdesivir is needed until a treatment that shows a definite effect is released.

 

Attention is focusing on whether the controversy over the efficacy will disappear through this review of the change permit.