The European Medicines Agency (EMA) announcement On November 19, 2021, it reviews currently available data on the use of Paxlovid, an oral COVID-19 treatment.
EMA is starting this EU-wide review to help national authorities who can decide on its early use before marketing authorization.
The results of the preliminary study indicate that Paxlovid reduced the risk of hospitalization or death compared to placebo when treatment was given within 3 or 5 days of the onset of symptoms of COVID-19.
Paxlovid is an oral antiviral protease inhibitor that reduces the ability of the SARS-CoV-2 coronavirus to multiply in the body.
The active substance PF-07321332 blocks the activity of an enzyme necessary for the coronavirus to multiply.
Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to stay in the body longer at levels that affect the virus.
If allowed, Paxlovid could be given at a dose of 300 mg (two 150 mg tablets) with one 100 mg tablet of ritonavir, given twice a day for five days.
The EMA’s executive director requested this expedited review following preliminary discussions with the EMA’s COVID-19 pandemic working group, bringing together experts from the European Medicines Regulatory Network.
The review is carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is responsible for matters relating to medicinal products for human use. The Committee will issue a scientific opinion as soon as possible.
Pfizer Inc. is also studying an investigational intravenous protease inhibitor, PF-07304814, which is currently in a Phase 1b multidose trial in hospitalized clinical trial participants with COVID-19.