It is now possible to use an oral treatment for COVID-19 in Korea.
The Ministry of Food and Drug Safety (MFDS) announced today (27th) that it has decided to approve the emergency use of Pfizer's edible Corona 19 treatment 'Paxrovid' in Korea.
This drug is an oral treatment for COVID-19 introduced for the first time in Korea, and the patient can take the pill for five days.
The Ministry of Food and Drug Safety's decision follows the request for emergency use authorization from the Korea Centers for Disease Control and Prevention on the 22nd.
Emergency Use Approval is a system in which manufacturers and importers supply unapproved medical products to Korea in order to properly respond to public health crises such as epidemics of infectious diseases.
The Ministry of Food and Drug Safety (MFDS) comprehensively considered the necessity of introducing an edible treatment due to the increase in the number of confirmed COVID-19 cases, the results of safety and effectiveness reviews, and the results of the expert advisory meeting. I made a decision.
At the advisory meeting, experts agreed that an emergency use authorization for Paxrovid is necessary in consideration of the domestic COVID-19 pandemic and clinical trial data.
In a Pfizer clinical trial, Paxrovid was found to reduce the risk of hospitalization or death by 88% in high-risk mild and moderate COVID-19 patients.
Side effects such as abnormal taste, diarrhea, increased blood pressure, and muscle pain were reported, but most of them were mild and there were no concerns about safety.
The Safety Management and Supply Committee for Public Health Crisis Response Medical Products also recognized the validity of emergency use approval in consideration of expert opinions, patient access, and choice of medical staff.
Paxrobead is a treatment for COVID-19 that inhibits virus proliferation by blocking proteolytic enzymes (3CL protease) from producing proteins necessary for virus replication.
Two tablets packaged together and can be stored at room temperature.
This drug is prescribed for COVID-19 patients with mild to moderate disease and children 12 years of age and older who are at high risk of progression to severe disease, taking into account age and underlying medical conditions.
The high-risk group established in the clinical setting is over 60 years of age or those suffering from obesity, chronic kidney disease, diabetes, cancer, chronic lung disease, cardiovascular disease, high blood pressure, etc.
One dose of this medicine consists of 2 tablets of 'Nirmatrelvir' and 1 tablet of 'ritonavir'.
Patients only need to take two doses per day for five days.
After diagnosis of COVID-19, the drug should be administered as soon as possible within five days of the onset of symptoms.
However, pregnant women are to administer it when the benefits outweigh the risks, and lactating women should stop breast-feeding after administering the drug.
Patients with severe hepatic impairment and renal impairment should not take this product, so you should consult with your healthcare provider.
The Ministry of Food and Drug Safety predicted that it would be effective for patients infected with various mutated Corona 19 viruses, including Omicron, due to the nature of Paxrobead, which inhibits virus proliferation in the body.
In vitro tests have already confirmed the antiviral effect on several mutated COVID-19 viruses except for Omicron, and Pfizer plans to submit the test results for the mutation of Omicron after approval for emergency use.
Choi Won-seok, a professor of infectious disease at Korea University Ansan Hospital, said, "The protein that Paxrovid blocks is a common site for all COVID-19 viruses. .
The Ministry of Food and Drug Safety announced that even after the emergency use approval of Paxrovid, it will continue to take measures for safe use, such as collecting side effects information.
Minister of Food and Drug Safety Kim Gang-lip said, "Unlike vaccines, Paxrovid will be managed through the Korea Pharmaceutical Safety Administration according to general drug adverse reaction treatment procedures." You just have to report it to the management,” he said.
The Ministry of Food and Drug Safety will take action considering patient safety as the top priority, such as evaluating and compensating for causality with the drug if side effects occur.
Director Kim said, “Paxrovid will contribute to diversifying treatment options depending on the patient’s situation along with the injection-type COVID-19 treatment currently being used in the field. It will help prevent it from getting seriously ill."
Currently, there are two types of injections for COVID-19 treatment approved in Korea: Gilead Science's Becluri (ingredient name: Remdesivir) and Celltrion's Lekkorina (ingredient name: Legdanvirab).
Becluri is prescribed for severe cases, and Lekkorina is prescribed for mild and moderate high-risk patients.
Meanwhile, the Ministry of Food and Drug Safety is reviewing emergency use approval for MSD's molnupiravir, another oral treatment for COVID-19, and is further confirming safety and effectiveness data.
On the 17th of last month, the Korea Centers for Disease Control and Prevention applied for emergency use authorization for molnupiravir.
The product name is 'Laguebrio'.
(Photo = Pfizer, provided by the Ministry of Food and Drug Safety, Yonhap News)