CHMP Recommends Pfizer's Paxlovid For Use In Adults With COVID-19

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 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.