The U.S Food and Drug Administration (FDA) approves Paxlovid for the treatment of mild-to-moderate COVID-19. In a press release On May 25, 2023, the FDA granted Pfizer approval for its antiviral medication for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The decision means the medication met regulatory safety and efficacy standards, and allows the Pfizer’s drug to remain on the market indefinitely.
Paxlovid is an important medication for the treatment of mild-to-moderate coronavirus in adults older than 50 and people with certain underlying medical conditions like diabetes, heart conditions, cancer or a weak immune system, amongst others. The data showed that Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause through 28 days of follow-up by 86% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 977 patients received Paxlovid, and 989 patients received placebo, and among these patients, 0.9% who received Paxlovid were hospitalized due to COVID-19 or died from any cause during 28 days of follow-up compared to 6.5% of the patients who received the placebo.
Dr. Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said: ”Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity.”
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