The European Medicines Agency (EMA) has announced that it is reviewing currently available data on the use of Paxlovid (ritonavir), an oral treatment for COVID-19 developed by Pfizer.
The EMA said in a statement that it was launching this evaluation to support national authorities who may decide to use Paxlovid early for COVID-19, for example in pre-marketing emergency settings.
The EMA Committee for Human Use (CHMP) will review data from a study comparing the effect of Paxlovid with that of placebo in untreated patients with mild to moderate COVID-19 symptoms who were at high risk of developing serious illness. Preliminary 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 onset of symptoms. The CHMP will also review data on the quality and safety of the drug.
While a more comprehensive rolling assessment is expected to begin before a possible marketing authorization application, this ongoing assessment will provide recommendations at EU level as soon as possible so that they can be used by national authorities wishing to make evidence-based decisions. with early use of the drug.
Authorities in the EU remain committed to speeding up the evaluation of much-needed treatments and vaccines for COVID-19, while ensuring that they meet the EU’s high standards of safety and efficacy. The EMA will report the outcome of this review as soon as it is completed.
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