Pfizer Receives EMA’s CHMP Positive Opinion of Paxlovid for COVID-19
- The EMA’s CHMP issued a positive opinion recommending the conversion of cMA for Paxlovid (SARS-CoV-2 Mpro inhibitor) to full MA for adults with COVID-19 who do not require supplemental oxygen & are at increased risk of the disease becoming severe. The EC’s final decision is expected shortly
- The recommendation was based on the totality of efficacy, safety & quality data. Paxlovid's advantages in assisting in lowering sev. COVID-19-related outcomes, such as hospitalization and death in high-risk patients continue to outweigh its potential risks
- Paxlovid was approved or authorized for conditional or emergency use in 70+ countries. It is generally administered at 300mg (two 150 mg tablets) of nirmatrelvir with one 100mg of ritonavir, BID for 5 days
Ref: Pfizer~ | Image: Pfizer
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