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MEDTECH Dive into the implications of the FDA’s approval of nirmatrelvir+ritonavir, the first oral antiviral pill for COVID-19.
The FDA’s recent approval of nirmatrelvir+ritonavir (Paxlovid, Pfizer) marks a significant advancement in COVID-19 treatment. This oral antiviral, the first of its kind, targets mild to moderate cases in high-risk adults. It’s the fourth drug, but the first pill, to gain FDA approval for treating adult COVID-19 patients.
Nirmatrelvir+ritonavir will remain available under emergency use authorization, ensuring continued access for adults and for eligible 12-18 year olds. However, it’s not approved for pre- or post-exposure COVID-19 prevention.
Patrizia Cavazzoni, MD, the director for the FDA’s Center for Drug Evaluation and Research, applauded the drug’s approval. She stressed the agency’s commitment to advancing new prevention and treatment options.
The efficacy of nirmatrelvir+ritonavir comes primarily from the EPIC-HR clinical trial. This trial studied nonhospitalized symptomatic adults diagnosed with SARS-CoV-2 infection. In the study, nirmatrelvir+ritonavir reduced COVID-19–related hospitalizations or deaths by 86% compared to placebo when used within five days of symptom onset.
Almost equal numbers of patients received nirmatrelvir+ritonavir and a placebo. Only 0.9% of the combo pill group were hospitalized or died within 28 days of follow-up, compared to 6.5% in the placebo group.
Interestingly, nirmatrelvir+ritonavir also benefited patients with prior immunity to the virus. Clinical trial data did not indicate a clear link between the Paxlovid treatment and COVID-19 rebound.
Prescribers must consider potential drug interactions with the combination. The FDA warns of the importance of reviewing all medications a patient is taking to assess for potential drug–drug interactions. Side effects include impaired taste and diarrhea.
The FDA is providing prescribers with extensive information on prescribing nirmatrelvir+ritonavir safely. In essence, this approval of Paxlovid is a significant milestone in the ongoing fight against COVID-19.
