The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending the conditional approval of Pfizer Inc's (NYSE:PFE) Paxlovid.
- Paxlovid (nirmatrelvir and ritonavir tablets) is indicated for COVID-19 in adults who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
- The CHMP based its positive opinion on the scientific evidence supporting PAXLOVID, including data from the Phase 2/3 EPIC-HR.
- 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.
- Related: Pfizer's COVID-19 Oral Antiviral Shows In-Vitro Efficacy Against Omicron Variant.
- Paxlovid is approved or authorized for emergency use in more than ten countries.
- Pfizer has raised its production projections, with the potential ability to produce up to 120 million courses of treatment by the end of 2022.
- PAXLOVID is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice daily for five days.
- Price Action: PFE shares are up 2.18% at $54.17 during the market session on the last check Thursday.
