EUA of Lagevrio imminent…interest focused on its treatment

Prevention rate of hospitalization and deaths at a 73% level compared to Paxlovid

MFDS will announce the review results on the 24th…expected to act as an substitute with its less contraindications

Whether the US company Merck (MSD)’s oral COVID-19 treatment Lagevrio (molnupiravir) will settle in Korea as an alternative to Paxlovid (nirmatrelvir, ritonavir) is gaining attention.

 

The company had applied for the emergency use authorization of molnupiravir to the Ministry of Food and Drug Safety in November last year but has not been granted EUA as of yet.

 

On the reason for the delay, some had evaluated that the delay was due to the lower efficacy of Lagevrio, whose rate of preventing hospitalization and deaths is 30% as compared to the 88% demonstrated by Paxlovid.

 

The MFDS had announced that it will decide upon Lagevrio’s EUA by 24th at the latest.

 

However, as the disease control and prevention authorities had already announced that it will bring in 100,000 courses of Lagevrio within the week, the prevailing view is that Lagevrio will be granted EUA.

 

Lagevrio is an RSA analog containing molnupiravir that induces virus deaths by being inserted in the place of the normal ribonucleic acid needed in the viral replication process.

 

Four 200mg capsules (800mg) of Lagevrio are to be taken twice a day for 5 days, totaling up to 40 capsules.

 

As for the period of administration, the drug is used in patients with mild symptoms of COVID-19, within 5 days of symptom onset.

 

The FDA had announced in December last year that Lagevrio’s rate of preventing hospitalization and deaths was 30%.

 

The drug is contraindicated in pregnant women, and some leukemia treatments are known to cause drug-drug interactions.

 

In the current situation, whether Lagevrio can show practical effect in treating COVID-19 as a substitute to Paxlovid in the case of its shortage is gaining attention.

 

The authorities believe that Lagevrio can be useful as Paxrovid, which is currently used in patients of all ages over 60, the immunocompromised, and those over 40 with underlying diseases, has many contraindications and is difficult to use in patients with impaired renal and liver function.

 

Eun-Kyeong Jeong, the commissioner of the Korea Disease Control and Prevention Agency (KDCA), had said, “The National Infectious Disease clinical committee had discussed on the need to introduce Lagevrio in patients that are ineligible for Paxlovid.

 

The WHO had also authorized limited use of Lagevrio in patients who cannot be prescribed Paxlovid.” Although Lagevrio’s prevention rate of hospitalization and deaths is at 73% that of Paxlovid,’ the need for its introduction has been growing due to the upsurge of new confirmed COVID-19 cases and the strict conditions required for Paxlovid’s administration.

 

The need for an alternative to Paxlovid has been increasing with the rising demand for oral tablets due to the upsurge of new COVID-19 cases in the medical field.

 

In particular, compared to Lagevrio, which is only contraindicated in pregnant women, and some leukemia treatments, the use of Paxlovid is much more restricted.

 

Paxlovid in patients with severe renal, liver impairment, and not allowed for use with 23 medicinal products including hypertension drugs, analgesics, angina drugs, arrhythmia drugs, gout drugs, sedatives, anticancer drugs, anticonvulsants, and some antifungal drugs.

 

The fact that one of the main ingredients of Paxlovid, ritonavir, has many contraindications and drug-drug interaction has affected the change in attitude towards Lagevrio.

 

As a result, after the Ministry of Food and Drug Safety decides on the emergency use of Lagevrio, how the drug will be used is expected to be determined according to the trend of new COVID-19 patient development and the prescription and medication status of Paxrovid.

 

Whether Lagevrio can broaden the range of options for patients who cannot take Paxlovid is also expected to affect the response of confirmed COVID-19 patients in the medical field.

 

The government has already signed an advance purchase agreement for 242,000 courses of Lagevrio.