EU starts real-time review of AZ Covid-19 antibody cocktail15 October 2021
Europe's drug regulator said on Thursday it had started a real-time review of the antibody-based COVID-19 therapy developed by AstraZeneca, roughly a week after the Anglo-Swedish drugmaker sought emergency approval from US authorities.
The decision to begin the assessment by the human medicines committee of the European Medicines Agency (EMA) was based on early results
from clinical studies, the regulator said in a statement https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab, without specifying when a conclusion was expected.
The medicine, the first protective shot other than vaccines against COVID-19, has proven to work in the non-infected and was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms.
"EMA will evaluate more data on the quality, safety and effectiveness of the medicine as they become available," the watchdog said, adding that the rolling review would continue until AstraZeneca submits a formal application for approval.