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Europe Expedites Oral COVID-19 Treatment Review

November 20, 2021 • 6:10 am CST
(Precision Vaccinations)

The European Medicines Agency (EMA) announced on November 19, 2021, it is reviewing currently available data on the use of Paxlovid, an oral COVID-19 treatment.

The EMA is starting this EU-wide review to support national authorities who may decide on its early use before marketing authorization. 

Preliminary study results indicate that Paxlovid reduced the risk of hospitalization or death compared with placebo when treatment was given within 3 or 5 days of the start of COVID-19 symptoms.

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 needed by the coronavirus to multiply.

Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus.

If authorized, Paxlovid could be administered at a dose of 300mg (two 150mg tablets) with one 100mg tablet of ritonavir, given twice daily for five days.

The EMA’s Executive Director requested this expedited review following preliminary discussions with EMA’s COVID-19 pandemic task force, bringing together experts from the European medicines regulatory network.

The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use. The Committee will issue a scientific opinion within the shortest possible timeframe.

Pfizer Inc. is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in Phase 1b multi-dose trial in hospitalized clinical trial participants with COVID-19.

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