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Pfizer’s Receives EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization of Paxlovid (nirmatrelvir and ritonavir) for COVID-19

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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

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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