EMA’s CHMP Grants Pfizer Thumbs Up for Paxlovid

The European Medicines Agency’s (EMA) human medicines committee has recommended a conditional marketing authorization for Pfizer’s COVID-19 oral antiviral Paxlovid.

The positive opinion by the Committee for Medicinal Products for Human Use (CHMP) was based on phase 2/3 study results showing Paxlovid (nirmatrelvir and ritonavir) reduced COVID-19-related hospitalization or death by 88 percent within five days of symptom onset vs. placebo.

A majority of patients in the trial contracted the Delta variant, but the expert panel noted that laboratory studies suggested Paxlovid is active against Omicron and other variants.