辉瑞新冠特效药：奈玛特韦片 nirmatrelvir/ritonavir

Drug Class

SARS-CoV-2 main protease (Mpro) inhibitor / PK enhancer combination

Mechanism

Nirmatrelvir inhibits the SARS-CoV-2 main protease (Mpro/3CLpro) to block viral replication, while ritonavir inhibits CYP3A4 to slow the metabolism of nirmatrelvir and increase its systemic concentration.

Approved Indication

Treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

What This Means For Patients

Paxlovid (nirmatrelvir/ritonavir) is an oral antiviral therapy approved by the FDA, EMA, and NMPA for the treatment of mild-to-moderate COVID-19 in high-risk patients. By inhibiting viral replication, it helps prevent hospitalization and progression to severe disease. It is available under clinical guidance.

Regulatory Approvals

• FDA — Approved (2021) — Sources
• EMA — Approved (2022) — Sources
• NMPA — Approved (2022) — Sources

Pivotal Clinical Evidence

• EPIC-HR — Hammond et al., N Engl J Med 2022 (NCT04960202) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf
• https://www.nmpa.gov.cn/