EMA evaluates currently available data on the use of Paxlovid (PF-07321332 / ritonavir), an oral treatment for the disease COVID-19, developed by Pfizer. EMA launches this assessment to support national authorities who may decide on early use of the drug to treat the disease COVID-19, such as in the event of an emergency, prior to its marketing authorization.
The Coreper Committee for Medicinal Products for Human Use (CHMP) will study data from a study comparing the effect of Paxlovid versus placebo in non-hospitalized patients with mild to moderate disease COVID-19 who are at high risk of developing serious disease. Preliminary results show that Paxlovid treatment, when given 3 to 5 days after the onset of symptoms, reduced the risk of hospitalization or death compared with placebo. The CHMP will also evaluate data on the quality and safety of the medicine.
As a more comprehensive rolling review is expected to begin in anticipation of a possible marketing authorization application, the existing evaluation will provide recommendations at EU level in the shortest possible time, which can be used by national authorities wishing to make informed decisions on early use of the drug.
EU authorities remain committed to speeding up the evaluation of much-needed treatments and vaccines for the disease COVID-19, while ensuring that they meet the EU 's high standards of safety and efficacy. Coreper will communicate the results of this evaluation upon completion.