China Announces Emergency Conditional Approval of Pfizer's Oral New Coronavirus Treatment Drug!

Just now, the official website of China's National Medical Products Administration (NMPA) announced that in accordance with the relevant provisions of the "Drug Administration Law", NMPA conducted emergency review and approval in accordance with the special drug approval procedures, and approved Pfizer's oral administration with conditions on February 11.
Import registration of small molecule novel coronavirus treatment drug nematevir tablet/ritonavir tablet combination package (trade name: Paxlovid)
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Image source: Screenshot of NMPA's official website The NMPA announcement pointed out that Paxlovid is an oral small-molecule new coronavirus treatment drug for the treatment of adults with mild to moderate new coronavirus pneumonia (COVID-19) patients with high risk factors for progression to severe disease.
For example, patients with severe risk factors such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease
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Patients should strictly follow the instructions for medication under the guidance of physicians, and should pay close attention to the interaction information with other drugs listed in the instructions during use
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NMPA requires that marketing authorization holders continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit follow-up research results in a timely manner
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Public information shows that Paxlovid consists of two main components: nirmatrelvir (PF-07321332) is a new coronavirus 3CL protease inhibitor, which can disrupt the subsequent RNA replication process of the new coronavirus by blocking the activity of the new coronavirus 3CL protease
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Another ingredient, ritonavir, allows nirmatrelvir to remain active in the body for longer and better fight the virus
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▲ Molecular formula of Nirmatrelvir (Image source: Michael D.
Turnbull, CC BY-SA 4.
0 <https://creativecommons.
org/licenses/by-sa/4.
0>, via Wikimedia Commons) In December 2021, Paxlovid was approved by the US FDA Emergency Use Authorization
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The data supporting this emergency use authorization come primarily from a randomized, double-blind, placebo-controlled clinical trial
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The trial enrolled adults who were positive for COVID-19 and who were not hospitalized but had symptoms
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None of these patients had been vaccinated against the new crown before and had never been infected with the new crown
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Clinical trial data show that Paxlovid can significantly reduce the risk of COVID-19-related hospitalization or all-cause death in patients
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Hospitalization or death was reduced by approximately 88% in the Paxlovid arm compared to the placebo arm (0.
8% in the treatment arm and 6% in the placebo arm)
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In addition, nine patients in the placebo control group died compared to zero in the treatment group
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The safety and efficacy of Paxlovid in the treatment of COVID-19 is still under further evaluation
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It is expected that Paxlovid will bring new treatment options to patients with COVID-19 after obtaining emergency conditional approval in China
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References: [1] The official website of the State Food and Drug Administration of China.
Retrieved Feb 12, 2022, from https:// Source | Compiled by Medicine Guanlan | Swagpp Click "Read" below Original" Download the Mace Medical APP