Reuters reports that
On Thursday, Europe’s drug regulator said it has begun a real-time examination of AstraZeneca’s (NASDAQ:AZN) antibody-based COVID-19 treatment, nearly a week after the Anglo-Swedish pharma requested emergency permission from US regulators.
The European Medicines Agency (EMA) stated in a statement https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab that the decision to begin the assessment was based on early findings from clinical trials, without indicating when a conclusion was expected.
The medication, the first protective injection against COVID-19 other than vaccinations, has been demonstrated to function in non-infected people and to save lives and avoid severe illness when administered within a week of the onset of symptoms.
“EMA will examine further evidence on the medicine’s quality, safety, and efficacy as they become available,” the watchdog said, adding that the rolling evaluation would continue until AstraZeneca submitted a formal application for approval.