MFDS approves emergency use of Pfizer’s oral COVID-19 drug

Used on Mild-to-moderate COVID-19 patients aged 12 or older at high risk of progressing to severe disease

Risk of hospitalization and death reduced by 88% when administered within 5 days after onset of symptoms or diagnosis

Will be administered to patients treated from home with doctor’s prescriptions… supplied by pharmacies

Pfizer’s oral COVID-19 treatment ‘Paxlovid’ received emergency use authorization in Korea as well.

 

Authorities plan to use the drug to treat adults and pediatric patients over the age of 12 with mild-to-moderate COVID-19 at high risk of progressing to severe disease.

 

Pharmacies will be supplying the pills for patients treated from their homes.

 

On the 27th, the Ministry of Food and Drug Safety announced that it had authorized the emergency use of ‘Paxlovid,’ an oral COVID-19 treatment developed by the US company Pfizer.

 

The decision was made after a comprehensive deliberation into the need to introduce oral treatment options that patients can self—administer amid the growing number of confirmed severe/critical COVID-19 cases and the MFDS’s safety/efficacy review results, as well as expert advisory meeting results at the ‘Public Health Crisis Response Medical Product Safety Management and Supply Committee.’ ‘Paxlovid’ is the first oral treatment to be introduced to Korea.

 

The government said that it plans to diversify treatment options that may be used by patients in addition to the shot-type treatment used in the field and expect the addition of Paxlovid to support the prevention of patients treated at residential treatment centers and home from progressing to severe diseases.

 

Paxlovid

Paxlovid inhibits a proteolytic enzyme (3CL protease) to prevent the production of proteins needed for virus replication and virus proliferation.

 

In a clinical trial that enrolled 2,246 non-hospitalized, mild-to-moderate COVID-19 patients at high risk of progressing to severe disease, the drug reduced COVID-19 hospitalization or death by 88% in patients who took the pill within 5 days of symptom onset.

 

In particular, the drug also showed the same effect in a clinical trial that enrolled around 300 Asians, including 19 Koreans.

 

The drug may be administered on adult patients and pediatric patients (12 and older weighing at least 40 kg) with mild-to-moderate COVID-19 that are at high risk of progressing to severe COVID-19 due to age, underlying disease, etc.

 

Paxlovid is administered as ‘three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally, twice daily for five days, and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset.

 

The Korea Disease Control and Prevention Agency (KDCA) has requested a priority review of ‘Paxlovid’ on the 22nd to the MFDS due to the rising need to introduce oral COVID-19 treatments that patients can take on their own in the process of returning to normal.

 

The MFDS has been conducting a preliminary review on the quality, clinical, and nonclinical data of ‘Paxlovid’ from November 10th before the KDCA requested a review for the emergency use approval.

 

Also, the ministry had received advice from external experts (9 people) in various fields including infectious diseases, respiratory medicine, toxicology, and virology.

 

As a result, experts agreed on the need to grant emergency use approval for ‘Paxlovid’ in consideration of the COVID-19 pandemic situation and the nonclinical and clinical trial results, and the feasibility of the subject patient population as proposed by the MFDS.

 

The MFDS said it will continue its efforts after granting the emergency use approval to collect information on adverse events that may arise in the process of using ‘Paxlovid’ while preparing further safety measures.

 

In addition, the authorities will request the company that imports Paxlovid to actively collect and report safety information on the drug and has improved related systems so that medical experts, as well as patients receiving treatment at residential treatment centers and homes, may report their side effects.

 

Also, through continuous analysis·assessment of safety information on Paxlovid in Korea and abroad, the authorities will make the safety measures necessary including precautions, discontinuations, and recalls.

 

With patient safety as a top priority, the authorities plan to take measures such as compensating for damages after evaluating the causality of the side effects that may occur.

 

An MFDS official said, “The drug may be used with doctors’ prescriptions.

 

However, as it is an oral pill rather than a shot, it will be distributed through pharmacies and supplied to patients that receive treatments at home.” Meanwhile, Paxlovid received emergency use authorization from the US FDA on the 22nd.