MFDS to Decide on 'Emergency Use Authorization' by 24th
KCDC Announces Plan to Administer Immediately After Authorization
'Paxlovid' Also Scheduled for Additional Import by End of March
[Asia Economy Reporter Ki Ha-young] The government will introduce 100,000 doses of Merck & Company (MSD)'s oral antiviral drug, Lagevrio, by the end of this month. This improvement measure was announced as the use of oral antiviral drugs has significantly increased due to the rise in confirmed cases caused by the spread of the Omicron variant.
On the afternoon of the 21st, Jeong Eun-kyung, Commissioner of the Korea Disease Control and Prevention Agency (KDCA), said at a regular briefing, "On the 11th, the National Infectious Disease Clinical Committee discussed the necessity of introducing MSD's Lagevrio for patients who cannot be prescribed Paxlovid due to hospital contraindications, kidney or liver disorders," adding, "Recently, the World Health Organization (WHO) also recommended limited use of Lagevrio in its treatment guidelines."
She continued, "The Ministry of Food and Drug Safety (MFDS) plans to decide on the emergency use authorization of Lagevrio within this week, and the KDCA plans to introduce and utilize 100,000 doses of Lagevrio by the end of March based on the MFDS review results."
The MFDS plans to announce the emergency use authorization decision for Lagevrio by the 24th at the latest. The MFDS stated, "The emergency use authorization decision is made by the MFDS Commissioner after review by the Public Health Crisis Response Medical Products Committee," and added, "Considering the serious situation, we will promptly convene the committee and announce the emergency use authorization decision for Lagevrio by Thursday (the 24th) at the latest." Furthermore, they noted, "Regarding safety concerns raised in non-clinical trials, we are reviewing restrictions on use for pregnant women and children."
Accordingly, actual prescriptions for Lagevrio will be guided after emergency use authorization. Commissioner Jeong said, "Once emergency use authorization is granted, negotiations are underway to introduce the drug as soon as possible," and "We will provide guidance on supply schedules and dosing plans immediately after the MFDS grants emergency use authorization."
Previously, the government completed a pre-purchase contract to import 242,000 doses of Lagevrio from MSD. The MFDS began reviewing the emergency use authorization for this drug on November 17 last year but had withheld approval after clinical trials showed that the drug's effectiveness in preventing hospitalization and death in high-risk mild to moderate patients was about 30%. In comparison, Pfizer's Paxlovid has an effectiveness of about 88% in preventing hospitalization and death.
Regarding concerns about the drug's effectiveness, Commissioner Jeong explained, "When the U.S. Food and Drug Administration (FDA) granted emergency use authorization in December last year, it showed about a 30% reduction in hospitalization or death. The WHO treatment guidelines indicate a 46% reduction in hospitalization, and a recent Phase 3 clinical trial conducted in India showed a 65% reduction. There is various information about the drug's effectiveness," adding, "The MFDS will explain the review results on the drug's efficacy, effectiveness, and safety in a separate briefing."
For patients eligible to use both Paxlovid and Lagevrio, the prescription of oral antiviral drugs will be determined by the physician. Commissioner Jeong said, "In such cases, doctors will decide based on the drug supply situation, the underlying conditions of the confirmed patients, and any medications they are currently taking," and requested, "Please follow the doctor's prescription."
Along with the introduction of Lagevrio, the quarantine authorities plan to additionally import Paxlovid by the end of this month. As of the previous day, a total of 163,000 doses of Paxlovid have been imported into the country, with 87,000 doses administered so far. The remaining stock is 76,000 doses. Since the first administration on January 14, the target groups for Paxlovid have been expanded to include those aged 60 and over, immunocompromised individuals, patients in their 50s with underlying conditions, and patients in their 40s with underlying conditions.
However, concerns about stock shortages have arisen due to the rapid increase in COVID-19 confirmed cases. The total weekly usage nearly doubled from 16,832 doses in the second week of March to 39,494 doses in the third week of March. Regarding this, Commissioner Jeong said, "At the current rate, the stock can last about two weeks, but prescriptions are increasing," and added, "We will secure additional quantities of Lagevrio so that it can be prescribed to high-risk groups who have difficulty receiving Paxlovid."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
