EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral to support national authorities who may decide on its early use for COVID-19, for example in emergency use settings, prior to marketing authorisation.

EMA’s human medicines committee (CHMP) will look at data from a study comparing the effect of Paxlovid with that of a dummy treatment (placebo) in non-hospitalised patients with mild to moderate COVID-19 who were at high risk of progressing to severe disease. The preliminary results indicate that Paxlovid reduced the risk of hospitalisation or death compared with placebo when treatment was given within 3 or 5 days of the start of symptoms. The CHMP will also review data on the medicine’s quality and safety.

While a more comprehensive rolling review is anticipated to start ahead of a possible application for a marketing authorisation, this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine.

Authorities in the EU remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy. EMA will communicate on the outcome of this review once it concludes.

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