(People's Daily Health Client Zhang Meng Chen Linhui)
On February 11, in accordance with the relevant provisions of the Drug Administration Law, the State Food and Drug Administration conducted emergency review and approval in accordance with the special drug approval procedures, and conditionally approved the import registration of Pfizer's new coronavirus treatment drug nematvir tablets/ritonavir tablets combination packaging (i.e., Paxlovid).
Suitable for people: Mainland China can only be used for adults, and the United States can only be used for people over 12 years old
According to the official website of the Mainland Food and Drug Administration, this product is an oral small molecule new coronavirus treatment drug, which is used to treat adults with mild to moderate novel coronavirus pneumonia (COVID-19) patients with high-risk factors for progression to severe disease, such as patients with severe risk factors such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease and other high-risk factors. Patients should strictly follow the instructions under the guidance of a physician, and pay close attention to the interaction information with other drugs listed in the instructions during use.
On December 22, 2021, the U.S. Food and Drug Administration (FDA) urgently approved Pfizer's oral COVID-19 drug Paxlovid for use in people over 12 years of age weighing at least 40 kg, making it the first approved oral COVID-19 drug in the United States, a 3CL protease inhibitor specifically designed to fight SARS-CoV-2. However, the U.S. Food and Drug Administration emphasizes that Paxlovid is not authorized for pre- or post-exposure prophylaxis of COVID-19 and is approved for the treatment of patients who require hospitalization due to severe or critical COVID-19.
Picture according to Xinhua News Agency.
Dosage Requirements: Twice daily for 5 days
According to the U.S. Food and Drug Administration (FDA), Paxlovid is composed of nirmatrelvir tablets and ritonavir tablets, which inhibit the replication of the SARS-CoV-2 protein, while ritonavir tablets can slow the breakdown of nematvir tablets and help drugs stay in the body for longer periods of time at higher concentrations. Treatment is followed by three pills, namely two nematvir tablets and one ritonavir tablet, taken orally twice daily for 5 days and not for more than 5 consecutive days.
The U.S. Food and Drug Administration stressed in a statement that Paxlovid is not a substitute for vaccination for individuals who recommend COVID-19 vaccines and booster doses.
Therapeutic effect: 89% reduction in the risk of death in hospitalization
In early November 2021, Pfizer released data on the therapeutic efficacy of its COVID-19 oral specific drug, which showed that it could reduce the risk of hospital death by 89%. PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy specifically designed for oral administration so that prescriptions can be prescribed when signs of infection or exposure are first realized to help patients avoid serious illness and death that could lead to hospitalization.
The main data supporting Paxlovid came from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial study of Paxlovid used to treat non-hospitalized symptomatic adults with laboratory-confirmed SARS-CoV-2 infection. The data showed that patients treated with PAXLOVID had an 89% lower risk of hospitalization or death from any cause associated with COVID-19 compared to placebo, with no deaths in the treatment group. Similar results were observed within five days of the onset of symptoms. And Pfizer said recent laboratory data show that Paxlovid is still effective against the Omiljun strain.
Notably, in addition to the U.S. FDA approval for listing, Pfizer has begun rolling submissions in several countries including the United Kingdom, Australia, New Zealand and South Korea, and plans to submit applications to other regulators around the world.
