EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG.
The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19.
EMA will assess the benefits and risks of Paxlovid under a reduced timeline and could issue an opinion within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.
Earlier, PharmProm.Net reported that Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.