KDCA “will monitor development of oral COVID-19 treatments"

to introduce such drugs to Korea

On the criticism regarding the improvement of clinical symptoms, the authority will comprehensively review treatments with verified efficacy.

Interim analysis of the Phase III trial on molnupiravir showed that the drug reduced risk of hospitalization and death by 50%.

The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co.

 

(MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in via a written inquiry about verifying the efficacy of molnupiravir after the NA audit that was held by the Health and Welfare Committee.

 

Seo asked,” The published results show patients who took placebo or molnupiravir until Day 5 and had no virus detection.

 

Authorities need to consider whether a drug this potent is necessary to increase relief among the public and as well as for disease containment." Regarding Seo’s inquiry, the KDCA said, “We have been reviewing the indications and clinical trial results from various countries." For the approval of an oral COVID-19 treatment the government plans to purchase, the authorities have been comprehensively reviewing various clinical trial results with various measures including the virus detection results, improvement in clinical symptoms, safety assessment, and the drug's approval status in advanced countries such as the United States.” In addition to the publsihed paper, Merck also announced the interim results of its clinical trial on mild-to-moderate patients at high-risk on October 1st.

 

Results showed that 28/385 of the patients who received molnupiravir were hospitalized or died within 29 days of administration compared to the 53/377 in the placebo group.

 

Deaths were reported in 0 patients that were administered molnupiravir and in 8 patients in the placebo group.

 

Also, the drug showed a consistent effect in all mutations, including the gamma, delta, and Mu variants.

 

Based on such results, the company has applied for the Emergency Use Authorization after discussions with the US FDA.

 

KDCA said, “we will continue to monitor COVID-19 treatments and endeavor to introduce safe and verified treatments to Korea."