Just now, the official website of China's State Food and Drug Administration (NMPA) announced that NMPA conducted emergency review and approval in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special drug approval procedures, and conditionally approved the import registration of Pfizer's oral small molecule new coronavirus treatment drug nematervir tablets/ritonavir tablets (trade name: Paxlovid) on February 11.
Image source: Screenshot of NMPA's official website
The NMPA announcement states that Paxlovid is an oral small molecule coronavirus treatment drug for the treatment of mild to moderate novel coronavirus pneumonia (COVID-19) in adults with a high risk factor for progression to severe disease, such as patients with severe risk factors such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. 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.
NMPA requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in a timely manner.
According to public information, Paxlovid is composed of two main components: nirmatrelvir (PF-07321332) is a new coronavirus 3CL protease inhibitor that can disrupt the subsequent RNA replication process of the new coronavirus by blocking the activity of the new coronavirus 3CL protease. Another ingredient, rignanvir, allows nirmatrelvir to remain active in the body for a longer period of time and better fight viruses.
Nirmatrelvir molecular formula (Credit: Michael D. Turnbull, CC BY-SA 4.0, via Wikimedia Commons)
In December 2021, Paxlovid was granted an emergency use authorization from the U.S. FDA. The data supporting this emergency use authorization came primarily from a randomized, double-blind, placebo-controlled clinical trial. The trial recruited adult patients who were confirmed to be COVID-19 positive, not yet hospitalized, but developed symptoms. None of these patients had received the COVID-19 vaccine before and had never been infected with COVID-19. Clinical trial data suggest that Paxlovid significantly reduces the risk of COVID-19-related hospitalization or all-cause death. Compared with the placebo control group, the proportion of patients in the Paxlovid group who were hospitalized or died decreased by about 88% (0.8% in the treatment group and 6% in the placebo control group). In addition, 9 patients died in the placebo control group, compared with 0 in the treatment group. The safety and efficacy of Paxlovid in treating COVID-19 is being further evaluated.
It is expected that Paxlovid will be able to bring new treatment options to COVID-19 patients after receiving emergency conditional approval in China.
bibliography:
[1] China State Food and Drug Administration. Retrieved Feb 12，2022, from https://www.nmpa.gov.cn/yaowen/ypjgyw/20220212085753142.html
Source | Medicine Guanlan
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