The Ministry of Food and Drug Safety said it granted emergency use approval (EUA) for Lagevrio (Ingredient: Molnupiravir), an oral Covid-19 treatment imported by MSD Korea, on Wednesday.

Lagevrio is the second oral Covid-19 treatment introduced in Korea. The ministry plans to use the drug in treating patients who have difficulty using injectable treatments or cannot take the existing oral treatment Paxlovid, such as those with severe hepatic or renal impairment.

The drug is a ribonucleoside (RNA) analog incorporated into viral RNA during the replication process of the Covid-19 virus to induce virus death.

The ministry explained that it decided after deliberation by the Public Health Crisis Response Medical Product Safety and Supply Committee in response to the need for a treatment alternative for high-risk, mild-to-moderate patients who cannot use existing treatments as the number of confirmed Covid-19 patients has recently increased significantly.

However, the ministry limited Lagevrio use only for patients not suitable for using Pfizer's Paxlovid or other injectable treatments.

According to the ministry, patients should take 800 mg of Lagevrio (four capsules of 200 mg) every 12 hours for five days. Patients should take the drug within five days after testing positive for Covid-19 and show the onset of symptoms.

However, the drug and food regulator stressed that pregnant women, children, and adolescents under 18 could not use the drug, noting that it would continue to collect information on side effects and additional safety measures after Lagevrio starts being prescribed in Korea.

The ministry has also asked MSD Korea to actively collect and report domestic and foreign safety information and establish a system where pharmaceutical experts and patients can report side effects by phone or online.

If serious side effects occur, the ministry will evaluate the causality and provide compensation.

"The government will do its best to contribute to the daily recovery of the people by supplying medical products necessary to overcome Covid-19 safely and quickly based on scientific knowledge and regulatory expertise," the ministry said.