Pfizer’s Receives EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization of Paxlovid (nirmatrelvir and ritonavir) for COVID-19
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- The CHMP opinion was based on the P-II/III (EPIC-HR) trial to evaluate Paxlovid vs PBO in non-hospitalized adults aged ≥18yrs. with COVID-19 who are at high risk of progressing to sev. illness
- The results showed a reduction in risk of hospitalization or death (89% vs 88%) within 3 & 5 days of symptom onset & no deaths were observed, TEAEs (23% vs 24%). The results have been submitted to a peer-reviewed publication
- Paxlovid is currently approved or authorized for emergency use in 10+ countries globally. Additionally, P-II/II clinical trials are currently ongoing in adults at standard risk of progressing to sev. illness who have been exposed to the virus through household contacts
Ref: Businesswire | Image: Pfizer
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