Pfizer receives CHMP positive opinion for Paxlovid ,a novel COVID-19 oral treatment.

The CHMP based its positive opinion on the scientific evidence supporting Paxlovid, including data from the Phase II/III EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data showed that Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, with no deaths observed in the treatment group. Treatment-emergent adverse events were comparable between Paxlovid (23%) and placebo (24%), most of which were mild in intensity. The data have been submitted to a peer-reviewed publication. Additional Phase II/III clinical trials are ongoing in adults at standard risk (i.e., low risk of hospitalization or death) of progressing to severe illness, and in those who have been exposed to the virus through household contacts.